Health Fraud Product Database

08/18/2026Esbelta Chupapanza Flat Bellyn/an/aelegantfigure.comUndeclared phenolphthaleinPublic NotificationDrugs 08/18/2026Esbelta Intense Lossn/an/aelegantfigure.comUndeclared sibutramine, desmethyl sibutramine, benzyl sibutramine and sildenafilPublic NotificationDrugs 08/12/2026Premium OrgaZEN 10000n/an/an/aUndeclared sildenafilPublic NotificationDrugs 08/12/2026Anaconda Premium 500Kn/an/an/aUndeclared tadalafilPublic NotificationDrugs 08/12/2026DMagic Plusn/an/alamilagrosalab.comUndeclared diclofenac, neriifolin and thevetin BPublic NotificationDrugs, FoodsAlert08/12/2026B. MAGIn/an/alamilagrosalab.comUndeclared phenolphthalein, neriifolin and thevetin BPublic NotificationDrugs, FoodsAlert07/23/2026Kangaroo Intense Venus 3000n/an/ausroyalhoney.comUndeclared sildenafilPublic NotificationDrugs 07/14/2026Xian Lingn/an/aVarious DistributorsUndeclared tapentadol and meloxicamPublic NotificationDrugs 07/14/2026Detoxi SlimPeople's Bazaar IIn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 07/01/2026MAGNUM XXL 300K Honeyn/an/aVarious DistributorsUndeclared sildenafil and tadalafilPublic NotificationDrugs 06/24/2026PRE-FORMANCE BLACKn/an/aadvancedsupps.comUndeclared 1,4-dimethylamylamine or DMAAPublic NotificationFoods 06/10/2026Branch Manager for Menn/an/asupplx.comUndeclared yohimbinePublic NotificationDrugs, Foods 06/10/2026Business Pilln/an/asupplx.comUndeclared yohimbinePublic NotificationDrugs, Foods 06/01/2026Dr. Yanhee Cream Set (Green)n/aThailandluessentials.storeSkin Product with Mercury and/or HydroquinoneAlertCosmetics, Drugs 06/01/2026Omni® GOLD Anti-Marks Cream Extra Brighteningn/aThailandebay.comSkin Product with Mercury and/or HydroquinoneAlertCosmetics, Drugs 06/01/2026Orbi 20® Whitening Creamn/aPakistanebay.comSkin Product with Mercury and/or HydroquinoneAlertCosmetics, Drugs 06/01/2026Jhalak® Hand & Foot Beauty Creamn/aPakistanebay.comSkin Product with Mercury and/or HydroquinoneAlertCosmetics, Drugs 06/01/2026La Crema De Rebecan/aUnknownlacremaderebeca.comSkin Product with Mercury and/or HydroquinoneAlertCosmetics, Drugs 06/01/2026La Crema De Rebecan/aUnknownebay.comSkin Product with Mercury and/or HydroquinoneAlertCosmetics, Drugs 06/01/2026Deluxe Silken Bleaching Creamn/aJamaicaebay.comSkin Product with Mercury and/or HydroquinoneAlertCosmetics, Drugs 06/05/2026Pink Pussycat brand productsn/an/aVarious websitesUndeclared sildenafil and tadalafilPublic NotificationDrugs 06/04/2026Lipofit Extreme 2.0 Fat Burnern/an/aanasalazar.us.comUndeclared fluoxetine and 2,4-dinitrophenol (DNP)Public NotificationDrugs 06/04/2026Juicy AF!n/an/aVarious DistributorsUndeclared sildenafilPublic NotificationDrugs 05/29/2026Taewon LiarBella's Nutri Shopn/abproductline.com; etsy.comUndeclared meloxicam, ketorolac, dexamethasone, and/or tapentadolPublic NotificationDrugs 05/29/2026Baipho Herbs Tea Drinkn/an/aamazon.comUndeclared piroxicamPublic NotificationDrugs 05/29/2026Big Dick Energy!n/an/aVarious DistributorsUndeclared tadalafilPublic NotificationDrugs 05/29/2026X10 Natural Enhancement Supplementn/an/anaturefuel.usUndeclared sildenafil and tadalafilPublic NotificationDrugs 05/29/2026Erectus Plusn/an/aebay.comUndeclared sildenafil, tadalafil and testosterone propionatePublic NotificationDrugs 05/29/2026Sensual Miracle Honeyn/an/aVarious DistributorsUndeclared sildenafil and tadalafilPublic NotificationDrugs 05/28/2026Better Weather Fix Elixir 15 mlBetter Weather Activities LLCSheridan, WYn/aUndeclared Mitragynine and Mitragynine Pseudoindoxyl (Kratom)RecallFoods 05/27/2026biQ-FELn/an/awalmart.com; biqfelusa.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 05/15/2026Sâm Xương Khớp Ông Tiênn/an/aongtienlinhchi.comUndeclared piroxicam and dexamethasone phosphatePublic NotificationDrugs 05/11/2026Better Weather Fix Elixir productsXD Investments LLCHouston, TXn/aUndeclared Mitragynine and Mitragynine Pseudoindoxyl (Kratom)RecallFoods 05/07/2026Hard AF!n/an/aVarious DistributorsUndeclared sildenafil and tadalafilPublic NotificationDrugs 05/05/2026RAPTURE Preworkoutn/an/aleaderformulas.comUndeclared 1,3-dimethylamylamine (DMAA)Public NotificationFoods 04/24/2026New Hyaluronic Acid 850 mg Sealed 30 Caps, Umaryibeautistore.com3042 Route 22 #38 Dover Plains, NY 12522-5920ibeautistore.comUndeclared diclofenac, dexamethasone and omeprazolePublic NotificationDrugsWarning Letter04/07/2026Yeicob Ácido HialurónicoRay's Vitamins6528 Greenleaf Avenue, Ste. 204 Whittier, CA 90601raysvitamins.comUndeclared dexamethasone phosphate and diclofenacPublic NotificationDrugsWarning Letter04/07/2026KUKA FLEX CBDn/an/aebay.comUndeclared diclofenacPublic NotificationDrugs 04/07/2026DINA Acido Hialurónicon/an/aebay.comUndeclared dexamethasone, methocarbamol, meloxicam and phenolphthaleinPublic NotificationDrugs 04/07/2026RM Joen/an/anaturistamexicanstore.comUndeclared dexamethasone phosphate and diclofenacPublic NotificationDrugs 04/07/2026Curcuflexn/an/aebay.comUndeclared dexamethasone and diclofenacPublic NotificationDrugs 04/07/2026UmaryVariousVarioussolovital.com; Main Products, Inc.; ebay.comUndeclared diclofenac, dexamethasone and omeprazolePublic NotificationDrugs

Recall

Additional Recall

Warning Letter

Drug Alert

04/06/2026WAP Sensual EnhancementBest Supplements Best PricesLos Angeles, CAebay.comUndeclared sildenafil, tadalafil and flibanserinPublic NotificationDrugsRecall04/03/2026Addall XR ShotZMB Enterprises, LLCCarlsbad, CAn/aContains 2-amino-6-methylheptane (DMHA) and undeclared 1,4-DMAAAlert  04/03/2026Addall-brand dietary supplementZMB Enterprises, LLCCarlsbad, CAn/aContains Phenibut (β-phenyl-GABA) and undeclared 1,4-DMAA (1,4-dimethylamylamine)Alert  03/26/2026Gold Lion Aphrodisiac Chocolate SachetGear IsleWest Sacramento, CAGear IsleUndeclared sildenafil and tadalafilRecallFoods, Drugs 03/14/2026Boner Bear HoneyPure Vitamins and Natural Supplements, LLCTampa, FLn/aUndeclared sildenafil and tadalafilRecallDrugsPublic Notification03/14/2026Red Bull ExtremePure Vitamins and Natural Supplements, LLCTampa, FLn/aUndeclared sildenafilRecallDrugsPublic Notification03/14/2026Blue Bull ExtremePure Vitamins and Natural Supplements, LLCTampa, FLn/aUndeclared sildenafilRecallDrugsPublic Notification03/13/2026Kian Pee WanAphresellerFlushing, NYebay.com; buy-herbal.comUndeclared dexamethasone and cyproheptadinePublic NotificationDrugsRecall03/11/2026Chupa PanzaNaturista Reyes (Suerte Y Salud LLC, La Tia Mana LLC)N/Aebay.comUndeclared yellow oleanderAlertFoods 02/26/2026ULTRA ADVANC3 GOLDn/an/anaturistarex.comUndeclared dexamethasone, diclofenac and methocarbamolPublic NotificationDrugs 02/26/2026ULTRA ADVANC3n/an/aamazon.comUndeclared dexamethasone, diclofenac and methocarbamolPublic NotificationDrugs 03/03/2026Artri Ajo Reyn/an/anaturistarex.comUndeclared dexamethasone, diclofenac and methocarbamolPublic NotificationDrugs 02/17/2026Advanced AlkaloidsShaman Botanicals, LLC1501 Iron Street North Kansas City, MO 64116cbdamericanshaman.comProduct contains 7-Hydroxymitragynine (7-OH) in an amount more than the declared value of 7.5 mg/tabletRecallFoods 02/13/2026Green Lumber (update)Green Lumber Holdings LLCar islegetgreenlumber.com, greenlumber.comUndeclared tadalafilPublic NotificationDrugs

Recall

Recall

02/13/2026LOVION Chocolate with Ginseng for Menn/an/alovionusa.comUndeclared sildenafil and tadalafilPublic NotificationFoods, Drugs 02/13/2026Fantasy Aphrodisiac Chocolaten/an/agearisle.comUndeclared sildenafilPublic NotificationFoods, Drugs 02/13/2026DTF Sexual ChocolateNalpacFerndale, MIshopsexology.comUndeclared sildenafil and tadalafilPublic NotificationFoods, DrugsRecall02/13/2026Boner Bears Chocolate SyrupLockout SupplementsMcKinney, TXlockoutsupplements.comUndeclared sildenafilPublic NotificationFoods, DrugsRecall02/13/2026Boner Bears Chocolate BarJXK Enterprises, Incn/aelyxr.comUndeclared sildenafilPublic NotificationFoods, DrugsRecall02/11/2026Pink Pussycat Aphrodisiac Chocolaten/an/aloverslane.comUndeclared tadalafilPublic NotificationFoods, Drugs 02/11/2026Rhino Choco VIPUSA LESS Co.Brooklyn, NYusaless.comUndeclared tadalafilPublic NotificationFoods, DrugsRecall02/11/2026ilum Male Sexual Enhancement ChocolateGear IsleWest Sacramento, CAebay.com; Gear IsleUndeclared sildenafil and tadalafilPublic NotificationFoods, DrugsRecall02/03/2026Ashfiat AlharamainAkkarco LLCLorton, VAakkarco.com; amazon.comUndeclared tadalafilRecallFoods 01/20/2026GELLEN TIME TO SHINE Nail Removal Kitn/an/aamazon.comContains methylene chlorideAlertCosmetics 01/20/2026MOROVAN GEL NAIL POLISH REMOVERMorovann/aamazon.comContains methylene chlorideAlertCosmeticsRecall01/20/2026EELHOE MAGIC REMOVERn/an/awalmart.comContains methylene chlorideAlertCosmetics 01/20/2026Candy Lover GEL POLISH REMOVERn/an/awalmart.comContains methylene chlorideAlertCosmetics 01/20/2026BORN PRETTY MAGIC GEL REMOVERn/an/aamazon.comContains methylene chlorideAlertCosmetics 01/20/2026NIFEISHI Nail Polish GEL REMOVERn/an/aamazon.comContains methylene chlorideAlertCosmetics 01/09/2026Modern Warrior ReadyModern WarriorPhoenix, AZn/aUndeclared tianeptine, 1,4-DMAA, and aniracetam.RecallDrugs, Foods 12/02/2025GE Labs YkarineGE Labs LLC8020 Excelsior Dr, Madison, WI 53717monsterking.euUndeclared trendione (estra-4,9,11-triene-3,17-dione)AlertDrugs 11/21/2025mR.7 SUPER 700000StuffbyNainax LLCHuntsville, TXebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugsRecall11/17/2025“Dr. Patels Measles Tablets"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025“Mans-Pachak Vati”Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025“Adel-54 Heart Care Drops"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025“Ayuvardhak Sutta Yog"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025“Parkikyor Tablets"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025“Ayuvardhak Sutta Yog"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025“Tri-Origin Ayurveda Diabetic Tablets"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025“Ayuvision Herbal Eye Drop"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025“Adel-17 Eye Care Drops"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025“Haslab Mamira Eye Drops"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comUnapproved new drugsWarning LetterDrugs 11/17/2025"Rheumacare Capsules"Handelnine Global, LLC dba Navafresh4300 S. Clinton Ave. South Plainfield, NJ 07080navafresh.comPresence of lead, unsafe levels of lead contaminationWarning LetterDrugsAlert11/13/2025“Ganoderma Huo Luo Dan”123Herbals7214 Berne St Rosemead, CA 91770123herbals.comUnapproved new drugsWarning LetterDrugs 11/13/2025“Hong Kong Vail Bon Tong”123Herbals7214 Berne St Rosemead, CA 91770123herbals.comUnapproved new drugsWarning LetterDrugs 11/13/2025“SAM NHUNG BO THAN”123Herbals7214 Berne St Rosemead, CA 91770123herbals.comUnapproved new drugsWarning LetterDrugs 11/13/2025“TDCARE”123Herbals7214 Berne St Rosemead, CA 91770123herbals.comUnapproved new drugsWarning LetterDrugs 11/13/2025“Vall Boon Antacid”123Herbals7214 Berne St Rosemead, CA 91770123herbals.comUnapproved new drugsWarning LetterDrugs 11/03/2025SiluetaYa Mexican Tejocote RootsSiluetaYa, LLC320 Gold Ave Sw Ste 620, Albuquerque NM USsiluetayausa.comUndeclared yellow oleanderRecallFoods 11/03/2025SdB ELITEOBC Group Corpn/anaturalvida.comUndeclared yellow oleanderAlertFoods 11/03/2025SdB Semilla de Brasil Tejocote RootOBC Group Corpn/aebay.comUndeclared yellow oleanderAlertFoods 10/27/2025“Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches”IBSPOT.com Inc.1414 Willow Avenue Elkins Park, PA 19027ibspot.comUnapproved new drugsWarning LetterDrugs 10/27/2025“Navabelle Motion Sickness Patches”IBSPOT.com Inc.1414 Willow Avenue Elkins Park, PA 19027ibspot.comUnapproved new drugsWarning LetterDrugs 10/23/2025SPARTANn/an/avroxusa.comUndeclared sildenafilPublic NotificationDrugs 10/23/2025vROXn/an/avroxusa.comUndeclared sidenafilPublic NotificationDrugs 10/17/2025Black Thai Honeyn/an/ahoneypack.comUndeclared sildenafil, tadafil, and diclofenacPublic NotiicationDrugs 10/17/2025Ashfiat Alharamain Energy Supportn/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 10/06/2025Osteo Sin Maxn/an/aebay.comUndeclared dexamethasone, methocarbamol, and phenylbutazonePublic NotificationDrugs 10/06/2025Mojo Max Fusion XXXn/an/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 10/03/2025Contra Reumasn/an/anaturistarex.comUndeclared dexamethasone, diclofenac, and methocarbamolPublic NotificationDrugs 09/30/2025Me Vale Madren/an/aebay.comUndeclared acetaminophen and diclofenacPublic NotificationDrugs 09/23/2025Agebox iKids Growth Day Formulan/an/aagebox.comUndeclared ibutamorenPublic NotificationDrugs 09/23/2025Agebox iKids Growth Night Formulan/an/aagebox.comUndeclared ibutamorenPublic NotificationDrugs 09/23/2025Flexi Bionn/an/aebay.comUndeclared dexamethasone and diclofenacPublic NotificationDrugs 09/23/2025SILINTAN123Herbals7214 Berne St Rosemead, CA 91770123herbals.comUndeclared meloxicamPublic NotificationDrugs

Warning Letter

Recall

09/18/2025Primal Herbs VolumePrimal Supplements Group LLCAlbuquerque, NMprimalherbs.comUndeclared sildenafilPublic NotificationDrugsRecall09/16/2025“StellaLife VEGA Oral Care Recovery Kit”Stellalife, Inc.P.O. Box 1204 Northbrook, IL 60065stellalife.comUnapproved new drugsWarning LetterDrugs 09/16/2025“StellaLife VEGA Oral Care Peppermint Gel"Stellalife, Inc.P.O. Box 1204 Northbrook, IL 60065stellalife.comUnapproved new drugsWarning LetterDrugs 09/16/2025“StellaLife VEGA Oral Care Spearmint Rinse”Stellalife, Inc.P.O. Box 1204 Northbrook, IL 60065stellalife.comUnapproved new drugsWarning LetterDrugs 09/16/2025“StellaLife VEGA Oral Care Peppermint Rinse”Stellalife, Inc.P.O. Box 1204 Northbrook, IL 60065stellalife.comUnapproved new drugsWarning LetterDrugs 09/16/2025“StellaLife VEGA Oral Care Coconut Rinse”Stellalife, Inc.P.O. Box 1204 Northbrook, IL 60065stellalife.comUnapproved new drugsWarning LetterDrugs 09/08/2025“Tianeptine Ethyl Ester Sulfate”PureRawz1404 Lakeshire Dr. Knoxville, TN 37922purerawz.coUnapproved new drugsWarning LetterDrugs 09/08/2025“Tianeptine Free-Acid"PureRawz1404 Lakeshire Dr. Knoxville, TN 37922purerawz.coUnapproved new drugsWarning LetterDrugs 09/08/2025“Tianeptine Sodium”PureRawz1404 Lakeshire Dr. Knoxville, TN 37922purerawz.coUnapproved new drugsWarning LetterDrugs 09/08/2025“Tianeptine Sulfate"PureRawz1404 Lakeshire Dr. Knoxville, TN 37922purerawz.coUnapproved new drugsWarning LetterDrugs 09/08/2025"Tianeptine Ultimate”PureRawz1404 Lakeshire Dr. Knoxville, TN 37922purerawz.coUnapproved new drugsWarning LetterDrugs 09/05/2025FTX PLUSn/an/awalmart.comUndeclared dexamethasone phosphate and diclofenacPublic NotificationDrugs 09/05/2025REUMA KINGn/an/aetsy.comUndeclared dexamethasone, diclofenac, and methocarbamolPublic NotificationDrugs 08/25/2025Green Vitality dba Gr33nGreen Vitality dba Gr33n1630 Peachtree Industrial Blvd Suwanee, GA 30024gr33n.comUnapproved new drugWarning LetterDrugs 08/25/2025“Similasan Allergy Eye Relief” (all variations)Supply Center USA30 N Gould St Ste R Sheridan, WY 82801supplycenterusa.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Similasan Complete Eye Relief"Supply Center USA30 N Gould St Ste R Sheridan, WY 82801supplycenterusa.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Similasan Computer Eye Relief”Supply Center USA30 N Gould St Ste R Sheridan, WY 82801supplycenterusa.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Similasan Pink Eye Relief"Supply Center USA30 N Gould St Ste R Sheridan, WY 82801supplycenterusa.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Similasan Redness & Itchy Eye Relief"Supply Center USA30 N Gould St Ste R Sheridan, WY 82801supplycenterusa.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Similasan Stye Eye Relief”Supply Center USA30 N Gould St Ste R Sheridan, WY 82801supplycenterusa.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Similasan Aging Eye Relief"Supply Center USA30 N Gould St Ste R Sheridan, WY 82801supplycenterusa.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Boiron Optique 1 Eye Irritation Relief”Supply Center USA30 N Gould St Ste R Sheridan, WY 82801supplycenterusa.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Jimerito (Melipona) Honey”Mel Honey US152 Wapiti Loop Hyrum, UT 84319-2012melhoney.us/Unapproved new drugWarning LetterDrugs 08/25/2025“Cineraria Maritima Eye Drops”Homeopathic Educational Services dba Homeopathic Family Medicine812 Camelia Street, Suite C Berkeley, CA 94710-1418homeopathic.comUnapproved new drugWarning LetterDrugs 08/25/2025“Holistic Honey EYE DROP” (also referred to on your website as “Jimerito Honey Eye Drops”)My Holistic Honey c/o Shenzhen Qanhai Wanb Express Supply Chain Co., LTD2452 Gillingham Circle Thousand Oaks, CA 91362myholistichoney.comUnapproved new drugWarning LetterDrugs 08/25/2025“Trew Vision CBD Eye Drops"Trew Balance11200 W. Michigan Ave. Suite #3 Youngtown, AZ 85363trewbalance.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Amazing Colyrio"Life Enthusiast Co-op711 S Carson Street Suite 4 Carson City, NV 89701life-enthusiast.comUnapproved new drugsWarning LetterDrugs 08/25/2025“Fulvic Eyes"Life Enthusiast Co-op711 S Carson Street Suite 4 Carson City, NV 89701life-enthusiast.comUnapproved new drugsWarning LetterDrugs 08/25/2025“MSM Gold Drops”Life Enthusiast Co-op711 S Carson Street Suite 4 Carson City, NV 89701life-enthusiast.comUnapproved new drugsWarning LetterDrugs 08/22/2025PAIN FLEXNaTerraHeriberto Jara 1817, Col. Jardines Alcalde, Guadalajara, Jalisco, MX 44290amazon.comUndeclared dexamethasone and methocarbamolPublic NotificationDrugs 07/22/2025FATZorbBeauty Collection International Pte Ltd90 Hougang Avenue 10, #03-08 HougangMall Singapore, 538766 SGebay.comUndeclared sibutramine, desmethyl sibutramine, benzyl sibutramine, and phenolphthalein Public NotificationDrugs 07/16/2025STNR Delta-8 and Delta-9 Gummies in various flavorsSTNR Creations, LLC6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810stnrcreations.comAdulterated human foodsWarning LetterFoods 07/16/2025STNR Delta-8 and Delta-9 Candy Clusters Nana Berry GummiesSTNR Creations, LLC6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810stnrcreations.comAdulterated human foodsWarning LetterFoods 07/16/2025STNR Delta-8 Gummies in various flavorsSTNR Creations, LLC6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810stnrcreations.comAdulterated human foodsWarning LetterFoods 07/16/2025STNR Delta-8 and Delta-9 Cookies in various flavorsSTNR Creations, LLC6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810stnrcreations.comAdulterated human foodsWarning LetterFoods 07/16/2025STNR Delta-8 and Delta-9 BrowniesSTNR Creations, LLC6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810stnrcreations.comAdulterated human foodsWarning LetterFoods 07/08/2025Versace Real Honey for MenSekerciler Tic. ve San. Ltd. Sti.2.Organize Sanayi Bolgesi2.Cadde No:11Yesilyurt, Malatya TR Various websitesUndeclared sildenafil, tadalafil, and acetaminophenPublic Notification Drugs 07/08/2025Black Horse Miracle Honey for MenSekerciler Tic. ve San. Ltd. Sti.2.Organize Sanayi Bolgesi2.Cadde No:11Yesilyurt, Malatya TRVarious websitesUndeclared sildenafil and tadalafilPublic NotificationDrugs 07/08/2025Secret Miracle Honey Extra StrengthSekerciler Tic. ve San. Ltd. Sti.2.Organize Sanayi Bolgesi2.Cadde No:11Yesilyurt, Malatya TRVarious websitesUndeclared sildenafil, tadalafil, and acetaminophenPublic NotificationDrugs 07/08/2025Black Panther Miracle Honey for MenSekerciler Tic. ve San. Ltd. Sti.2.Organize Sanayi Bolgesi2.Cadde No:11Yesilyurt, Malatya TRVarious websitesUndeclared sildenafil, tadalafil, and acetaminophenPublic NotificationDrugs 06/24/2025Toki Slimming CandyHoang Huy Investment & Trading Co., Ltd. 84 Street 23, Giao Luu City Urban Area, Co Nhue 2 Ward, Bac Tu Liem District, Hanoi, Vietnamebay.comUndeclared sibutraminePublic NotificationFoods 05/15/2025DolotrexInnovacion Natural10910 Long Beach Blvd., Suite 103-402, Lynnwood, CA 90262innvocaionnatural.comUndeclared diclofenacPublic Notification Drugs 05/15/2025UmovyEREN NATURALS SA DE CVCalle Tepame Paraisos De 1518Col. Paraisos Del Colli, ZapopanZapopan, Jalisco MXumovy-usa.comUndeclared dexamethasone and diclofenacPublic NotificationDrugsRecall05/15/2025UnavyEREN NATURALS SA DE CVCalle Tepame Paraisos De 1518Col. Paraisos Del Colli, ZapopanZapopan, Jalisco MXumary-usa.comUndeclared dexamethasone, diclofenac, and omeprazolePublic NotificationDrugsRecall05/06/2025Endurance BoostEnShiShiXiangNiShangMaoYouXianGongSi150-67 Northern Blvd. Flushing, NY 11354amazon.comUndeclared propoxyphenylsildenafil and sildenafilRecallDrugs 04/25/2025Male Ultra ProHealth FixerTempe, AZ 85288amazon.comUndeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafilRecallDrugs 04/25/2025Ultra ArmorHealth FixerTempe, AZ 85288amazon.comUndeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafilRecallDrugs 04/25/2025Electro BuzzHealth FixerTempe, AZ 85288amazon.comUndeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafilRecallDrugs 04/25/2025MalextraHealth FixerTempe, AZ 85288amazon.comUndeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafilRecallDrugs 04/25/2025Male UltraHealth FixerTempe, AZ 85288amazon.comUndeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafilRecallDrugs 04/25/2025Artrifan KingOmega NutritionJorge Washington No 108, Col. Las Americas, Hidalgo Del Parral, Chihuahua, MX, 33880artriking.usUndeclared dexamethasone, diclofenac, and methocarbamolPublic NotificationDrugs 04/23/2025Pain Flex ForteNaTerraHeriberto Jara 1817, Col. Jardines Alcalde, Guadalajara, Jalisco, MX 44290ibspot.comUndeclared dexamethasone and diclofenacPublic NotificationDrugs 02/28/2025AL'IVER® Nail Polish Quick Gel Remover n/aChinaamazon.comContains methylene chlorideAlertCosmetics 02/28/2025AL’IVER® Professional MAGIC REMOVERn/aChinaamazon.comContains methylene chlorideAlertCosmetics 02/28/2025AIBRIT Gel Nail Polish Removern/aChinaamazon.comContains methylene chlorideAlertCosmetics 02/28/2025BesTby Gel Nail Polish Removern/aChinaamazon.comContains methylene chlorideAlertCosmetics 02/10/2025ADVANCE KINGn/an/anaturistastore.comUndeclared dexamethasone, diclofenac, and methocarbamolPublic NotificationDrugs 02/10/2025bio LITn/an/aVarious websitesUndeclared 1,4-dimethylamylamine (DMAA) Public NotificationFoods 02/10/2025Special Edition Platinum 10Kn/an/aVarious websitesUndeclared acetaminophen, tadalafil and vardenafilPublic NotificationDrugs 02/10/2025vROXn/an/aVarious websitesUndeclared sildenafilPublic NotificationDrugs 02/10/2025HimGon/an/aebay.comUndeclared sildenafilPublic NotificationDrugs 02/10/2025VITALITYOne Source NutritionBenton, ARzen-herbs.comUndeclared sildenafil and tadalafilPublic NotificationDrugsRecall12/27/2024Natural MiracleZEN Platinum 70000n/an/aVarious websitesUndeclared tadalafil and sildenafilPublic NotificationDrugs 12/27/2024RIGIDRXn/an/aVarious websitesUndeclared tadalafilPublic NotificationDrugs 12/27/2024The Goatn/an/aVarious websitesUndeclared sildenafilPublic NotificationDrugs 12/27/2024X3 500L GOLD EDITION n/an/aVarious websitesUndeclared tadalafil and sildenafilPublic NotificationDrugs 12/26/2024Rhino 69 Gummyn/an/aVarious websitesUndeclared tadalafilPublic NotificationDrugs 12/26/2024Lucky Guy Platinum 18000n/an/aVarious websitesUndeclared tadalafilPublic NotificationDrugs 12/26/2024Rhino 11 Gummyn/an/aVarious websitesUndeclared tadalafilPublic NotificationDrugs 12/26/2024Rhino Gummy Royal 50000n/an/aVarious websitesUndeclared tadalafilPublic NotificationDrugs 12/19/2024WILDMANn/an/aloveproducts.netUndeclared sildenafil, tadalafil, sibutramine, desmethyl sibutramine and phenolphthaleinPublic NotificationDrugs 12/13/2024VidaSlim 90-day (Original Root, Root Plus, and Root Capsules)Motivate Me Ashley, LLCSan Antonio, TXVidaslim Co./Vidaslim USAContains undeclared yellow oleanderAlertFoodsRecall12/13/2024VidaSlim 30-day (Original Root, Root Plus, and Root Capsules)Motivate Me Ashley, LLCSan Antonio, TXVidaslim Co./Vidaslim USAContains undeclared yellow oleanderAlertFoodsRecall12/13/2024VidaSlim 7-day Sample Size (Original Root, Root Plus, and Root Capsules)Motivate Me Ashley, LLCSan Antonio, TXVidaslim Co./Vidaslim USAContains undeclared yellow oleanderAlertFoodsRecall12/13/2024VidaSlim Hot Body Brew (Strawberry and Peach flavors)Motivate Me Ashley, LLCSan Antonio, TXVidaslim Co./Vidaslim USAContains undeclared yellow oleanderAlertFoodsRecall12/10/2024Fouzee Sugarlin Herbal Formula capsulesShoppers-PlazaLos Angeles, CAshoppers-plaza.comUndeclared metformin and glyburidePublic NotificationDrugsRecall12/03/2024New Me n/an/aShopnewmeroot.comContains undeclared yellow oleanderAlertFoods 11/27/2024LipoFit Turbon/an/an/aUndeclared sibutramine, metformin, fluoxetine, and furosemide Public NotificationDrugs 11/22/2024THERMO SHOCKn/an/ascilabsnutrition.comUndeclared 1,3-dimethylamylamine (1,3-DMAA)Public NotificationFoods 11/22/2024Force ForeverGNMART INCDover Plains, NYgnmart.comUndeclared diclofenac and dexamethasonePublic NotificationDrugsRecall11/19/2024HON-E-LINGn/an/aExamination of imported goodsUndeclared sibutramine and sildenafilPublic NotificationDrugs 11/19/2024UmaryMXBBBn/aamazon.comUndeclared diclofenac and omeprazoleRecallDrugs 11/08/2024VITAFER-L Gold 10mln/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 11/08/2024VITAFER-L Gold 20mln/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 11/08/2024VITAFER-L Gold 500mlNatural Dior LLCn/aamazon.com; www.walmart.comUndeclared tadalafilPublic NotificationDrugsRecall11/06/2024PeakMax CapsulesVitalityVitaSacramento, CAvitalityvita.comUndeclared sildenafil and diclofenacRecallDrugsPublic Notification11/06/2024VitalityXtra CapsulesVitalityVitaSacramento, CAvitalityvita.comUndeclared sildenafilRecallDrugsPublic Notification11/04/2024ZapMax CapsulesBoulla LLCSacramento, CAamazon.comUndeclared sildenafil and diclofenacRecallDrugsPublic Notification11/04/2024ZoomMax CapsulesBoulla LLCSacramento, CAamazon.comUndeclared sildenafil and diclofenacRecallDrugsPublic Notification11/01/2024Nhan Sam Tuyet Lien Truy Phong Hoann/aFlushing, NYbuy-herbal.comUndeclared chlorpheniramine, dexamethasone and furosemidePublic NotificationDrugsRecall10/30/2024ITCHA XSn/an/aExamination of international mail shipmentsUndeclared fluoxetine or bupropionPublic NotificationDrugs 10/30/2024OneMultivitaminic GAF-Plus Advancen/an/alipoblueadvance.comUndeclared dexamethasone, acetaminophen, and aspartamePublic NotificationDrugs 10/30/2024Skin-Cap aerosol spray productsChemigroup France, formerly known as Cheminova Laboratoriesn/askincap.com; amazon.com; walmart.comUndeclared high-potency glucocorticosteroidDrug AlertDrugs 10/07/2024Trinity Goldn/an/atrinitygoldnutrition.comUndeclared acetaminophen, diclofenac and phenylbutazonePublic NotificationDrugs 10/02/2024Body Shape Weight Loss Systemn/an/aExamination of international mail shipmentsUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 09/26/2024Ácido Hialurónicon/an/aebay.comUndeclared diclofenacPublic NotificationDrugs 09/11/2024AK ForteC&A NaturisticsNational City, CAproductosnaturalesca.com, ebay.com, etsy.comUndeclared acetaminophen and diclofenacPublic NotificationDrugs

Warning Letter

Recall

09/05/2024Amazyn/an/avarious websites, including SoloVital, Main Products and Amazon, and in some retail storesUndeclared diclofenac and omeprazoleDrug AlertDrugsPublic Notification08/21/2024Boom MaxBoulla LLCSacramento, CAamazon.comUndeclared sildenafil and acetaminophenRecallDrugs 07/30/2024RMSOL GRACIANn/an/abotanical-be.comUndeclared diclofenacPublic NotificationDrugs 07/30/2024SILI PHARMAn/an/abotanical-be.comUndeclared diclofenacPublic NotificationDrugs 07/26/2024Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratomn/an/an/aProduct label indicates the presence of kratom alkaloids, mitragynine and 7-hydroxymitragynine (7-OH mitragynine)Safety AlertFoods 07/10/2024Vail-Bon Jie Yang Wan123herbalsRosemead, CAeverymarket.comUndeclared dexamethasone and chlorpheniraminePublic NotificationDrugs

Warning Letter

Recall

07/10/2024Gold Hard Steel PlusSupercore Products GroupAtlanta, GAhardsteelusa.comUndeclared sildenafilPublic NotificationDrugsRecall07/05/2024Hard SteelSupercore Products GroupAtlanta, GAhardsteelusa.comUndeclared sildenafil and acetaminophenPublic NotificationDrugsRecall06/28/2024Diamond ShruumzProphet Premium BlendsSanta Ana, CAdiamondshruumz.comProducts contain MuscimolRecallFoodsInvestigation of Illnesses06/20/2024Infla-650Guru Inc.Lilburn, GAnutraherbusa.com; nutra650.comUndeclared acetaminophen, diclofenac and phenylbutazonePublic NotificationDrugsRecall06/14/2024La Paixn/an/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 04/17/2024Ossos-Sansn/an/ahttps://alnaturaleshop.comUndeclared diclofenac and methocarbamolPublic NotificationDrugsWarning Letter04/05/2024Eva Nutrition Mexican Tejocote rootGlobal Mix, Inc.New Yorketsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.comPublic NotificationRecallFoods 04/05/2024Science of Alpha Mexican Tejocote rootGlobal Mix, Inc.New Yorketsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.comContains undeclared yellow oleanderRecallFoods 04/05/2024NWL Nutra Mexican Tejocote rootGlobal Mix, Inc.New Yorketsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.comContains undeclared yellow oleanderRecallFoods 04/05/2024Niwali Mexican Tejocote rootGlobal Mix, Inc.New Yorketsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.comContains undeclared yellow oleanderRecallFoods 04/04/2024Elv Control Herbal SupplementWorld Green Nutrition, Inc.n/an/aContains undeclared yellow oleanderRecallFoods 02/29/2024SNAKE BONES Anti-Rheumatic Capsulesn/an/an/aUndeclared piroxicamPublic NotificationDrugs 02/29/2024QUICK Rheumatism Capsule, Tiger Wang Biaodn/an/an/aUndeclared piroxicamPublic NotificationDrugs 01/30/2024ArizeToday the Worldn/agetarize.comUndeclared nortadalafilPublic NotificationDrugsRecall01/30/2024SchwinngToday the World; STOP CLOPEZ CORPn/aschwinnng.com; amazon.comUndeclared nortadalafilPublic NotificationDrugs

Recall

Additional Recall

01/30/2024Sustain®Today the Worldn/asustainformula.com; amazon.comUndeclared tadalafil and avanafilPublic NotificationDrugsRecall01/26/2024nwl NUTRA Mexican Tejocote Rootn/an/aamazon.comContains undeclared yellow oleanderAlertFoods 01/26/2024EVA NUTRITION Mexican Tejocote RootGlobal Mix Inc.n/aeva-nutrition.comContains undeclared yellow oleanderAlertFoods 01/26/2024ELV King All Natural Tejocote RootSunset Sales +n/aamazon.comContains undeclared yellow oleanderAlertFoods 01/26/2024ELV King Tejocote Root Raiz de TejocoteSunset Sales +n/aamazon.comContains undeclared yellow oleanderAlertFoods 01/26/2024ALIPOTEC Tejocote Root Dietary Supplement PiecesALIPOTEC RAIZ DE TEJOCOTEn/aalipotectejocote.comContains undeclared yellow oleanderAlertFoods 01/26/2024Science of ALPHA Mexican Tejocote RootNatural Supplements, LLCn/atejocotemexican.comContains undeclared yellow oleanderAlertFoods 01/26/2024H & Natural Tejo Root Raiz de TejocoteH and Naturaln/ahandnatural.comContains undeclared yellow oleanderAlertFoodsRecall01/26/2024H & Natural Brazil SeedH and Naturaln/ahandnatural.comContains undeclared yellow oleanderAlertFoodsRecall01/26/2024ALIPOTEC Tejocote Root Raiz de TejocoteBackstage CTC Sellern/aamazon.comContains undeclared yellow oleanderAlertFoodsRecall01/26/2024ALIPOTEC Tejocote Root Dietary Supplement Piecesn/an/aamazon.comContains undeclared yellow oleanderAlertFoods 01/26/2024Nutraholics ELV Tejocote Root Dietary Supplement Piecesn/an/aamazon.comContains undeclared yellow oleanderAlertFoods 01/26/2024Nutraholics ELV Nutraking Mexican Tejocote Root Supplement Piecesn/an/aamazon.comContains undeclared yellow oleanderAlertFoods 01/26/2024ALIPOTEC Tejocote Rootn/an/aamazon.comContains undeclared yellow oleanderAlertFoods 01/26/2024Niwali Raiz de TejocoteGlobal Mix, Inc.n/aetsy.comContains undeclared yellow oleanderAlertFoods 01/26/2024Science of Alpha Mexican Tejocote RootGlobal Mix, Inc.n/aetsy.comContains undeclared yellow oleanderAlertFoods 01/26/2024ALIPOTEC Tejocote Root Dietary Supplement PiecesInnovacion Natural, LLCn/ainnovacionnatural.comContains undeclared yellow oleanderAlertFoods 01/26/2024Tejocotex Tejocote RootPastor-Villareal, Inc.n/aamazon.comContains undeclared yellow oleanderAlertFoods 01/26/2024ALIPOTEC ELV Mexican Tejocote RootAlipotec South TX; World Green Nutrition, Inc.n/aalipotecus.comContains undeclared yellow oleanderAlertFoods 01/12/2024ELV Alipotec Mexican Tejocote Root Supplement PiecesWorld Green Nutrition, Inc.n/an/aContains undeclared yellow oleanderRecallFoods 01/02/2024ENDUREAn/an/aamazon.comUndeclared tadalafil and sildenafilPublic NotificationDrugs 01/02/2024ForeverMenn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugsRecall01/02/2024Seraphim Zn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugs 01/05/2024Blue Boy Herb Co. products, including Arthritis Formula, Blood Tonic, Diabecon, Brain Tonic, Gout Formula, Gravel Formula, Heart Tonic, Liver Tonic, Lung Tonic, Oats +, Poke Root Formula, Poke Root Salve, Pressex, Rumalaya, Sacred Meditation Oil, Turmeric Tincture, and UterineBlue Boy Herb Company10060 Road 263Carriere, MS 39426https://blueboyherbs.comNew DrugOnline Advisory LetterFoods; Drugs 12/26/2023Wild Bulln/an/aamazon.comUndeclared nortadalafilPublic NotificationDrugs 12/26/2023TO THE MOONn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugsRecall12/26/2023T XTRA Strength Test Boostern/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 12/26/2023Ram Itn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugsRecall12/21/2023Govvi WOW!n/an/aebay.comUndeclared 1,4-dimethylamylamine (DMAA)Public NotificationFoods 11/29/2023Magnum XXL 9980Meta HerbalE. Hampton, NYamazon.comUndeclared sildenafilRecallDrugs 11/21/2023Neptune's Fixn/an/an/aContains tianeptineAlertDrugs 11/17/2023Himalayan Pain Relief TeaWS Global, IncBrooklyn, NYhimalayan-painrelieftea.comUndeclared diclofenac and dexamethasonePublic NotificationDrugsRecall11/17/2023Tepee Herbal Tean/an/aamazon.comUndeclared piroxicamPublic NotificationDrugs 11/17/2023Notoginseng Formula Special Gout Granulen/an/aebay.comUndeclared dexamethasone and diclofenac Public NotificationDrugs 11/03/2023Dr. Ergin's SugarMD Advanced Glucose Supportn/an/asugarmds.comUndeclared Glyburide and MetforminPublic NotificationDrugsRecall10/19/2023The RockNoah’s Wholesale, LLCn/an/aUndeclared sildenafilPublic NotificationDrugsRecall09/29/2023Reumo Flexn/an/abotanical-be.comUndeclared diclofenac Public NotificationDrugsRecall09/29/2023Kuka Flex Forten/an/abotanical-be.comUndeclared diclofenac Public NotificationDrugsRecall08/31/2023Tapee Tean/an/atapeetea.comUndeclared dexamethasone and piroxicamPublic NotificationDrugs 08/22/2023BIG GUYS Male Energy Supplementn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugs 08/22/2023Mens Maximum Energy Supplementn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugs 08/22/2023Round 2n/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 08/22/2023Genergyn/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 08/22/2023WeFunn/an/aamazon.com; eshoponlineusa.comUndeclared sildenafilPublic NotificationDrugsRecall08/22/2023X MAX Triple Shot Energy Honeyn/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 08/09/2023Vegetal Vigra 200mgn/an/aAPG Seven, Inc.Undeclared sildenafilPublic NotificationDrugs 05/17/2023AnnieCare Natural Repair Vaginal CapsulesPresilky dba Burhealthy.comn/aburhealthy.comNew drugsOnline Advisory LetterFoods; Drugs 05/11/2023V=GRA GOLD 500mgn/an/aVariousUndeclared sildenafilPublic NotificationDrugs 05/08/2023Fast-Act Rheuma Capsulen/an/aVariousUndeclared prednisone-21-acetate and piroxicam Public NotificationDrugs 05/08/2023New Fast-Act Rheumatism Capsulen/an/aVariousUndeclared indomethacin Public NotificationDrugs 05/08/2023UA-Blockn/an/aVariousUndeclared indomethacin Public NotificationDrugs 05/05/2023Platinum 69000 Rhino 69n/an/aVariousUndeclared sildenafilPublic NotificationDrugs 05/05/2023Power Plus Desiren/an/aVariousUndeclared sildenafilPublic NotificationDrugs 05/05/2023Rhino 7S Type F3 7000n/an/aVariousUndeclared sildenafil and acetaminophenPublic NotificationDrugs 05/05/2023Phentamene XTn/an/aVariousUndeclared DMAAPublic NotificationFoods 05/04/2023Hard Steel 300Kn/an/aVariousUndeclared tadalafilPublic NotificationDrugs 05/04/2023Diamond Girl Liten/an/aVariousUndeclared sildenafilPublic NotificationDrugs 05/04/2023Special Edition Platinum 10Kn/an/aVariousUndeclared tadalafil and vardenafilPublic NotificationDrugs 05/01/2023NORF 20n/an/aInternational Mail ShipmentsUndeclared acetaminophen, salicylic acid, and theophyllinePublic NotificationDrugs 04/19/2023DYNAMITE Male Sexual Enhancementn/an/agearisle.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 04/19/2023NUX Male Sexual Enhancementn/an/agearisle.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 04/19/2023Pro Power Knight Plus 2550mgn/an/agearisle.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 04/13/2023AK Forten/an/asuprimoimports.comUndeclared diclofenac, dexamethasone, and methocarbamol Public NotificationDrugs 04/07/2023Tantra Jelly Herbal Jelly for Himn/an/aInternational Mail ShipmentsUndeclared sildenafil and tadalafilPublic NotificationDrugs 04/07/2023American Bangster Black Label Optimum Formula 4000n/an/aamericanbangster.comUndeclared tadalafilPublic NotificationDrugs 04/07/2023American Bangster Optimum Formula 3000n/an/aamericanbangster.comUndeclared tadalafil and sildenafilPublic NotificationDrugs 04/07/2023NORF 20n/an/aInternational Mail ShipmentsUndeclared acetaminophen, salicylic acid, and theophyllinePublic NotificationDrugs 02/16/2023Tawon Liarn/an/abproductline.com; etsy.comUndeclared meloxicam, ketorolac, and dexamethasonePublic NotificationDrugs 02/08/2023Alfia Weight Loss Capsulesn/an/aalfia.comUndeclared sibutraminePublic NotificationDrugs 02/07/2023PrimeZen Black 6000n/an/avoltcandy.comUndeclared sildenafil and tadalafilPublic NotificationDrugsRecall02/02/2023MANNERS Energy Boostn/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 12/21/2022B.B. Clear Dark Spot Remover Creamn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022Amos Make Me White in 7 Daysn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022African Queen Strong Bleaching Treatmentn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022Light & Natural CAROTONE Black Spot Corrector CREME B.S.Cn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022HIYADY Glutatione Cream White & Brightn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022Aneeza Gold Beauty Face Creamn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022Collagen Plus - Vit E Cream, Night Creamn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022Skin care & Cosmetic MSII Express Peelingn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022Skin care & Cosmetic MSII Whitening Peelingn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022Ling Zhi BB Whitening Creamn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022La Tia Mana Crema Limpiadora y Curativan/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022Be Be Special Creamn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022Be Be Special Cream CCM/Yellown/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022CCM Perfect 365 White Creamn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 12/21/2022CCM Special Cream Turmericn/an/aVariousSkin Product with Mercury and/or HydroquinoneAlertCosmetics/Drugs 11/21/2022JACK'D Sexual Enhancement Liquidn/an/aVariousUndeclared sildenafilPublic NotificationDrugs 11/21/2022JACK'D Sexual Enhancement Capsulesn/an/aVariousUndeclared sildenafilPublic NotificationDrugs 11/14/2022CoQ10 UbiquinolAnabolic Laboratories Inc26021 Commercentre Dr. Lake Forest, CA 92630-8853anaboliclabs.comNew Drug/MisbrandedWarning LetterFoods 11/14/2022PrimePolicosanol MicrotabsAnabolic Laboratories Inc26021 Commercentre Dr. Lake Forest, CA 92630-8853anaboliclabs.comNew Drug/MisbrandedWarning LetterFoods 11/14/2022BPS-5 Healthy Trends Worldwide, LLC11011 Spring Point Cir Riverview, FL 33579-4303goldenafter50.comNew Drug/MisbrandedWarning LetterFoods 11/14/2022Blood Pressure Support Chambers' Apothecary278 Lincoln Way, East Chambersburg, PA 17201chambersapothecary.comNew Drug/MisbrandedWarning LetterFoods 11/14/2022CoEnzyme Q10 productsChambers' Apothecary278 Lincoln Way, East Chambersburg, PA 17201chambersapothecary.comNew Drug/MisbrandedWarning LetterFoods 11/14/2022iwi Cholesteroliwi2800 Post Oak Blvd Suite 5858 Houston, TX 77056iwilife.comNew Drug/MisbrandedWarning LetterFoods 11/14/2022Cholesterol CommandBergaMet North America LLC6445 S. Tenaya Way Suite B110 Las Vegas, NV  89113-1989bergametna.comNew Drug/MisbrandedWarning LetterFoods 11/14/2022CholestAid Essential Elements675 N. 2800 W #101 Lindon, UT 84042essentialelementsnutrition.comNew Drug/MisbrandedWarning LetterFoods 09/28/2022Wonder Pill CapsulesProper Trade LLC/My Stellar Lifestylen/aamazon.com; walmart.comUndeclared tadalafilRecallDrugs 08/02/2022SANGTER Energy Supplement, 3000mgDistributor RFR, LLCMiami, FLsangter.com and retail storesUndeclared sildenafilRecallDrugsPublic Notification07/28/2022Honeymoon Exclusive For Men & Womenn/an/aExamination of imported goodsUndeclared tadalafil and sildenafilPublic NotificationDrugs 07/25/2022SustangoUltra Supplement LLCWilmington, DEamazon.comUndeclared tadalafil RecallDrugs 07/22/2022Lipopastilla + Gold Maxn/an/alipopastillas.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 07/15/2022Adam's Secret Extra Strength Bluen/an/aadamssecret.comUndeclared tadalafil Public NotificationDrugs 07/15/2022Adam's Secret Extra Strength Purplen/an/aadamssecret.comUndeclared tadalafil and sildenafilPublic NotificationDrugs 07/15/2022Adam's Secret Extra Strength Amazing Blackn/an/aadamssecret.comUndeclared tadalafilPublic NotificationDrugs 07/15/2022Adam's Secret Extra Strength 300 Platinum (White Packaging)n/an/aadamssecret.comUndeclared tadalafilPublic NotificationDrugs 06/27/2022Launch Sequence CapsulesLoud Muscle Science, LLCn/aamazon.com, amazon.ca, ebay.com, and retail storesUndeclared tadalafilRecallDrugs 06/27/2022Launch Sequence Euphoria CapsulesLoud Muscle Science, LLCn/aamazon.com, amazon.ca, ebay.com, and retail storesUndeclared tadalafilRecallDrugs 06/27/2022Launch Sequence Aphrodisia CapsulesLoud Muscle Science, LLCn/aamazon.com, amazon.ca, ebay.com, and retail storesUndeclared tadalafilRecallDrugs 04/25/2022Kingdom Honey Royal Honey VIPShopaax.com2 Burleigh Ct., Newark, DE 19702shopaax.comUndeclared sildenafilPublic NotificationDrugs

Warning Letter

Recall

04/25/2022Cougar Secret Honey VIPn/an/agreenvalleyshops.comUndeclared sildenafilPublic NotificationDrugs 04/25/2022Medcare Golden Royal Honeyn/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 04/25/2022HoneyGizer™n/an/aamazon.comUndeclared sildenafilPublic NotificationDrugs 04/25/2022ETUMAX VIP Royal Honey for Himn/an/ahoneyworldusa.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 04/25/2022Erkexinn/an/aaliexpress.comUndeclared sildenafilPublic NotificationDrugs 04/25/2022Royal Honey VIPThirsty Run LLC / US Royal Honey LLC6841 Ternes St. Dearborn, MI 4812thirstyrun.com; usroyalhoney.comUndeclared tadalafilPublic NotificationDrugsWarning Letter04/25/2022Secret Miracle Honey (for Women)n/an/ausroyalhoney.comUndeclared sildenafilPublic NotificationDrugs 04/25/2022Secret Miracle Honey (for Men)n/an/aetsy.comUndeclared sildenafilPublic NotificationDrugs 04/25/2022Vital HoneyMKS Enterprise, LLC59 Paulison Ave. #13 Passaic, NJ 0705wholesaleonline1.com; thirstyrun.comUndeclared tadalafilPublic NotificationDrugs

Warning Letter

Warning Letter

Recall

04/25/2022Helmi's Honey VIPn/an/aamazon.com; walmart.comUndeclared tadalafilPublic NotificationDrugsNews Release04/25/2022X Rated Honey for Men1am USA Incorporated dba Pleasure Products USA6603 Crimson Lane Barnhart, MO 63012pleasureproductsusa.com; amazon.comUndeclared tadalafilPublic NotificationDrugsWarning Letter04/20/2022Ortiga Mas Ajo Rey Extra Forten/an/aebay.comUndeclared diclofenac, dexamethasone and methocarbamolPublic NotificationDrugsAlert04/20/2022Ortiga Mas Ajo Reyn/an/aamazon.comUndeclared diclofenacPublic NotificationDrugsAlert04/20/2022Artri Kingn/an/aamazon.com, latinfoodsmarket.com, walmart.comUndeclared dexamethasone and diclofenacPublic NotificationDrugs

Alert

Recall

Recall

03/04/2022Wonderful Honeyn/an/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 02/10/2022Rise Up Red Edition CapsulesPositive-Healthn/aamazon.comUndeclared tadalafilRecallDrugs 02/09/2022Red Mammoth capsulesCelebrate Todayn/aamazon.comUndeclared tadalafil and sildenafilRecallDrugs 02/08/2022The Red PillYour Favorite Shopn/aamazon.comUndeclared tadalafilRecallDrugs 02/08/2022MAC DADDY PURPLE capsules ABC SALES 1 INCn/aamazon.comUndeclared tadalafilRecallDrugs 02/08/2022MAC DADDY RED capsulesABC SALES 1 INCn/aamazon.comUndeclared tadalafil and sildenafilRecallDrugs 02/04/2022MegMan Performance Booster capsulesJunp LLCn/aamazon.comUndeclared tadalafilRecallDrugs 01/28/2022Hard Dawn Rise and Shine capsules Esupplementsales, LLCn/aamazon.comUndeclared tadalafilRecallDrugs 01/05/2022Artri Ajo KingVarious Distributorsn/aamazon.comUndeclared diclofenacPublic NotificationDrugsAlert01/02/2022NasitrolAmcyte Pharma, Inc.5400 Carillon Point, Kirkland, WA 98004nasitrol.comUnapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/08/2021AvaphinalVarious Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugsNews Release12/08/2021Brahma Male EnhancementVarious Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugsNews Release12/08/2021Hard AF!Various Distributorsn/awalmart.comUndeclared sildenafil and acetaminophenPublic NotificationDrugsNews Release12/08/2021Jaguar PowerVarious Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugsNews Release12/08/2021Kangaroo Intense Alpha 3000Various Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugsNews Release12/08/2021Magnum XXL 9800Various Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugsNews Release12/08/2021Pink PussycatVarious Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugs

News Release

Recall

12/08/2021Go On RedVarious Distributorsn/awalmart.comUndeclared tadalafilPublic NotificationDrugsNews Release12/01/2021“VitaStik” product lineVitaStik, Inc.433 N. Camden Dr. #600, Beverly Hills, CA 90210vitastik.comUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information12/01/2021“VitaCig products”VitaCig, Inc.2375 Watermill Dr., Orange Park, FL 32073vitaciggroup.comUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information12/01/2021“vaporizer” and “diffuser” productsNV Nutrition, LLC4700 140th Ave N. Suite 112, Clearwater, FL 33762nutriair.comUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information12/01/2021“B12 VITAMINVAPE”Vitamin Vape, Inc.6320 S. Sandhill Road, Suite 5, Las Vegas, NV 89120vitaminvape.coUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information12/01/2021“Caffeine Pen”Eagle Energy USA, Inc.27 N. 27th Street, Suite 2102, Billings, MT 59101-2347eagle.energyUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information11/18/2021Crocin productsSaffron Health Sciences13 Dexter Rd, E Brunswick, NJ 08816saffronhealthsci.com; facebook.com/saffronhealthsci/; amazon.com;New Drug/MisbrandedWarning LetterFoods 09/28/2021Non-alcohol-based topical antiseptic product, microSURE™Strategia Project Management, Inc.1000 Jorie Blvd. Suite 370 Oak Brook, IL 60523microsure.com; twitter.com/microsure_; facebook.com/microSURE.HandSanitizerUnapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 09/22/2021ArsynSupplement Science Corp. d/b/a Condemned Labz2139 East 3rd Street Brooklyn, NY 11223condemnedlabz.com/; facebook.com/condemnedlabzofficialUnapproved New Drugs/MisbrandedWarning LetterFoods 09/22/2021ConvictStimSupplement Science Corp. d/b/a Condemned Labz2139 East 3rd Street Brooklyn, NY 11223condemnedlabz.com/; facebook.com/condemnedlabzofficialUnapproved New Drugs/MisbrandedWarning LetterFoods 09/22/2021HumaslinSupplement Science Corp. d/b/a Condemned Labz2139 East 3rd Street Brooklyn, NY 11223condemnedlabz.com/; facebook.com/condemnedlabzofficialUnapproved New Drugs/MisbrandedWarning LetterFoods 09/22/2021ThyrogenicSupplement Science Corp. d/b/a Condemned Labz2139 East 3rd Street Brooklyn, NY 11223condemnedlabz.com/; facebook.com/condemnedlabzofficialUnapproved New Drugs/MisbrandedWarning LetterFoods 09/22/2021DNA DispatchSupplement Science Corp. d/b/a Condemned Labz2139 East 3rd Street Brooklyn, NY 11223condemnedlabz.com/; facebook.com/condemnedlabzofficialUnapproved New Drugs/MisbrandedWarning LetterFoods 09/10/2021“Glyco-Well”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Pan-Gest”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Heart-Line”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Aspara-Can”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Cherry Gold”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“H.H.S. Formula”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Brain Balance”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Passionate Pursuit”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Better Mood”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Male Prosexual”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Ear Well”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Pink Lady”Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021“Eye-C” Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/10/2021Hemorr-Norm” Holographic Health, Inc.516 E. Market Street Kingsport, TN 37660holographichealth.comNew Drug/MisbrandedWarning LetterFoods 09/07/2021“Black Indian Salve,” also referred to as “Indian Herb,” “X,” and “Black Salve”McDaniel Water LLC363 Ricketson Road Amistad, NM 88410mcdanielwater.com Unapproved New Drugs/MisbrandedWarning LetterDrugs 09/07/2021CuraLin Radhanite, LLC d/b/a Curalife Ltd208 Paterson Plank Rd. Union City, NJ 07087-2826curalife.com/; instagram.com/curalife/ and https://www.facebook.com/curalife/Unapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021Sugar BalanceAceva, LLC624 West Glen Ave. Peoria, IL 61614aceva.com/; twitter.com/acevahealth and https://www.facebook.com/acevanutritionUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021Diabetes Support Ar-Rahman Pharm LLC14625 Baltimore Ave., Suite 885 Laurel, MD 20707ar‐rahmahpharm.com/; instagram.com/arrahmahpharm/; facebook.com/ArRahmahPharmUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021“Lysulin Weight Loss Shake”Lysulin, Inc.4930 Bradshaw Ct. San Diego, CA 92130lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagementUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021“Lysulin Diabetes and Prediabetes Chewables”Lysulin, Inc.4930 Bradshaw Ct. San Diego, CA 92130lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagementUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021“Lysulin Diabetes and Prediabetes Liquid”Lysulin, Inc.4930 Bradshaw Ct. San Diego, CA 92130lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagementUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021“Lysulin Diabetes and Prediabetes Capsules”Lysulin, Inc.4930 Bradshaw Ct. San Diego, CA 92130lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagementUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021“Lysulin Diabetes and Prediabetes Powder”Lysulin, Inc.4930 Bradshaw Ct. San Diego, CA 92130lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagementUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021“Berry Gen Sugar Control”Live Good Inc.860 NW 27th St. Suite 051-51425 Miami, FL 33122berrygen.com/; facebook.com/ColagenoBerryGenRestore/; instagram.com/berrygenrestore/Unapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021"GLUCOTYPE2”Phytag Labs12600 Hill Country Boulevard Suite R-275 Bee Cave, TX 78738phytagelaboratories.com; amazon.comUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021“Diabetic Support Formula”Nuturna International LLC390 North Orange Ave. Suite 2300 Orlando, FL 32801nuturna.com; amazon.comUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021“Diabetes Doctor Pre-Diabetes”Pharmaganics LLC8475 Parley Lake Rd Waconia, MN 55387diabetesdoctor.com; facebook.com/naturaldiabetesdoctor; instagram.com/diabetesdoctor/Unapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021“Diabetes Doctor Blood Sugar 24 Hour”Pharmaganics LLC8475 Parley Lake Rd Waconia, MN 55387diabetesdoctor.com; facebook.com/naturaldiabetesdoctor; instagram.com/diabetesdoctor/Unapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021DiabetesSupportMetamune Inc8001 S 194th St. Kent, WA 98032-1126bodymune.com/; facebook.com/Bodymune/; amazon.comUnapproved New Drugs/MisbrandedWarning LetterFoods 09/07/2021Diabalance Diabetes SupplementHolistic Healer & Wellness Center, Inc.3998 Clippert St. P.O. Box 23017 Dearborn, MI 48123holistichealeronline.comUnapproved New Drugs/MisbrandedWarning LetterFoods 08/31/2021Muscle TestNew York Nutrition Company / American Metabolix1083 FM 812 Unit B Cedar Creek, TX 78612-3689americanmetabolix.comUnapproved New Drugs/MisbrandedWarning LetterFoods 08/31/2021BanishNew York Nutrition Company / American Metabolix1083 FM 812 Unit B Cedar Creek, TX 78612-3689americanmetabolix.comUnapproved New Drugs/MisbrandedWarning LetterFoods 08/31/2021Ketogenic Diet AidNew York Nutrition Company / American Metabolix1083 FM 812 Unit B Cedar Creek, TX 78612-3689americanmetabolix.comUnapproved New Drugs/MisbrandedWarning LetterFoods 08/31/2021Keto Friendly CollagenNew York Nutrition Company / American Metabolix1083 FM 812 Unit B Cedar Creek, TX 78612-3689americanmetabolix.comUnapproved New Drugs/MisbrandedWarning LetterFoods 08/31/2021Exile Euphoric Weight LossNew York Nutrition Company / American Metabolix1083 FM 812 Unit B Cedar Creek, TX 78612-3689americanmetabolix.comUnapproved New Drugs/MisbrandedWarning LetterFoods 08/31/2021Exile Super ShockNew York Nutrition Company / American Metabolix1083 FM 812 Unit B Cedar Creek, TX 78612-3689americanmetabolix.comUnapproved New Drugs/MisbrandedWarning LetterFoods 08/31/2021Havok HardcoreNew York Nutrition Company / American Metabolix1083 FM 812 Unit B Cedar Creek, TX 78612-3689americanmetabolix.comUnapproved New Drugs/MisbrandedWarning LetterFoods 08/31/2021Keto Pump in Watermelon and Grape FlavorsNew York Nutrition Company / American Metabolix1083 FM 812 Unit B Cedar Creek, TX 78612-3689americanmetabolix.comUnapproved New Drugs/MisbrandedWarning LetterFoods 08/26/2021Fibrolief Support FormulaFibromyalgia Treatment Group - FTG, LLC1236 Lone Creek Drive Eagle, ID 83616fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibroliefNew Drug/MisbrandedWarning LetterFoods 08/26/2021Nerve RenewFibromyalgia Treatment Group - FTG, LLC1236 Lone Creek Drive Eagle, ID 83616fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibroliefNew Drug/MisbrandedWarning LetterFoods 08/26/2021Neuro Boost OptimizerFibromyalgia Treatment Group - FTG, LLC1236 Lone Creek Drive Eagle, ID 83616fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibroliefNew Drug/MisbrandedWarning LetterFoods 08/26/2021Immune SupportFibromyalgia Treatment Group - FTG, LLC1236 Lone Creek Drive Eagle, ID 83616fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibroliefNew Drug/MisbrandedWarning LetterFoods 08/24/2021ISM5 Invisi Smart MaskInvisi Smart Technologies UK LTD112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdominvisismart.com/; shop.invisismart.com/; twitter.com/InvisiSmartAdulterated and Misbranded Products Related to Coronavirus Disease 2019Warning LetterDevices 08/24/2021ISM5 Invisi Smart Mask (Black Edition)Invisi Smart Technologies UK LTD112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdominvisismart.com/; shop.invisismart.com/; twitter.com/InvisiSmartAdulterated and Misbranded Products Related to Coronavirus Disease 2019Warning LetterDevices 08/24/2021ISM30 Invisi Smart Mask Invisi Smart Technologies UK LTD112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdominvisismart.com/; shop.invisismart.com/; twitter.com/InvisiSmartAdulterated and Misbranded Products Related to Coronavirus Disease 2019Warning LetterDevices 08/19/2021“Patanjali Coronil Kit” (aka “Patanjali Divya Swasari Coronil Kit”)Mahita, LLC dba PushMyCart415 Hillingdon Way Suwanee, GA 30024pushmycart.com; facebook.com/pushmycartglobalUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 08/19/2021“Dr. Reckeweg Arsenic Album Dilution 30 CH"Mahita, LLC dba PushMyCart415 Hillingdon Way Suwanee, GA 30024pushmycart.com; facebook.com/pushmycartglobalUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 08/19/2021“SBL Arsenicum Album Dilution 30 CH"Mahita, LLC dba PushMyCart415 Hillingdon Way Suwanee, GA 30024pushmycart.com; facebook.com/pushmycartglobalUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 08/19/2021“Kerala Ayurveda Balarishtam"Mahita, LLC dba PushMyCart415 Hillingdon Way Suwanee, GA 30024pushmycart.com; facebook.com/pushmycartglobalUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 08/19/2021“Kottakkal Balarishtam”Mahita, LLC dba PushMyCart415 Hillingdon Way Suwanee, GA 30024pushmycart.com; facebook.com/pushmycartglobalUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 08/18/2021Themra Epimedyumlu Bitkisel Karisimli MacunVarious Distributorsn/aExamination of imported goods - shipment addressed to an Amazon fulfillment centerUndeclared sildenafilPublic NotificationDrugs 08/10/2021Various salt scrub productsSecret of the Islands5326 Bush River Rd. Columbia, SC 29212secretoftheislands.com; facebook.com/SecretoftheIslandsUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 08/06/2021Modified Perilla & MenthaBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Empowered CordycepsBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Empowered ReishiBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021AllerEaseBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Empowered EleuthroBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Sui Bian GuoBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Chinese Herbal ShampooBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Jade Dew OintmentBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Stop Pain TinctureBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Dr. Bob’s Medicated OilBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Cut & Sore OintmentBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021E-C-Z OintmentBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Organic Cactus Seed (Prickly Pear) Oil Antioxidant Facial SerumBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Skin Soothing OintmentBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021Dragon’s Blood LinimentBlue Poppy Enterprises Inc4804 SE 69th Avenue Portland, OR 97206bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.comNew Drug/MisbrandedWarning LetterFoods 08/06/2021"Genesis Ultra Gold" Genesis Nutrition Ultra Slim dba Genesis Ultra Slim10108 NW 77th Street Doral, FL 33178fastweightlossgarcinia.com; ketoultraslimplus.com; facebook.com/genesisultraslim; twitter.com/genesis_slim; instagram.com/genesis_slim/Unapproved New Drugs/MisbrandedWarning LetterDrugs 08/03/2021Non-alcohol-based consumer antiseptic nasal product, "NanoBio® Protect Over-The-Counter Nasal Antiseptic"Blue Willow Biologics2311 Green Road Ann Arbor, MI 48105nanobioprotect.com; bluewillow.com; cvs.com/shop/nanobio-protect-nasal-antiseptic-prodid-160333Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs*08/02/2021365 Skinny High Intensity Pills Je Dois L’avoir Boutiquen/ajedoisavoir2020.comUndeclared sibutramineRecallDrugs 08/02/2021365 Skinny Emergency BoutiqueJe Dois L’avoir Boutiquen/ajedoisavoir2020.comUndeclared sibutramineRecallDrugs 07/29/2021Neutralization Antibody Test kit (Colloidal Gold, Fluorescent, Elisa)Lepu Medical Technology -Beijing- Co., Ltd.No. 37 Chaoqian Rd.Changping Qu Beijing Shi,Chinan/aAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/29/2021SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)Lepu Medical Technology -Beijing- Co., Ltd.No. 37 Chaoqian Rd.Changping Qu Beijing Shi,Chinan/aAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/29/2021Saliva Antigen Rapid TestLepu Medical Technology -Beijing- Co., Ltd.No. 37 Chaoqian Rd.Changping Qu Beijing Shi,Chinan/aAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/28/2021Melatonin Dr. Thomas Polucki Upper Cervical Chiropractic, Inc.25050 Peachland Ave #105 Newhall, CA 91321getbetterxshop.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 07/28/2021Nitric Oxide SupportDr. Thomas Polucki Upper Cervical Chiropractic, Inc.25050 Peachland Ave #105 Newhall, CA 91321getbetterxshop.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 07/26/2021Hydro Pinapple [sic] BurnMax Health; eBay Seller - jongu 4308Houston, TXebay.comUndeclared sibutramine and desisobutylbenzylsibutraminePublic NotificationDrugsRecall07/26/2021“COVx-RDA Nasal Antigen Test”Vivera Pharmaceuticals, Inc.26021 Pala Drive - St A Mission Viejo, CA 92691viveracovid19.com/covx-rda/; viverapharmaceuticals.com/products/Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/26/2021“COVxRDA Saliva Antigen Test”Vivera Pharmaceuticals, Inc.26021 Pala Drive - St A Mission Viejo, CA 92691viveracovid19.com/covx-rda/; viverapharmaceuticals.com/products/Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/26/2021VIVERA + OMECARE Home Specimen Collection KitVivera Pharmaceuticals, Inc.26021 Pala Drive - St A Mission Viejo, CA 92691hometestbox.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/23/2021Organic Blueberry White & Green TeaTeaTaze, LLC1203 N Fieldcrest St Wichita, KS 67212teataze.com; facebook.com/teatazeteaNew Drug/MisbrandedWarning LetterFoods 07/23/2021Clean Green Energy Detox TeaTeaTaze, LLC1203 N Fieldcrest St Wichita, KS 67212teataze.com; facebook.com/teatazeteaNew Drug/MisbrandedWarning LetterFoods 07/23/2021Tokusen Hinshucha Fuji Midori Green TeaTeaTaze, LLC1203 N Fieldcrest St Wichita, KS 67212teataze.com; facebook.com/teatazeteaNew Drug/MisbrandedWarning LetterFoods 07/23/2021Vibrant Green TeaTeaTaze, LLC1203 N Fieldcrest St Wichita, KS 67212teataze.com; facebook.com/teatazeteaNew Drug/MisbrandedWarning LetterFoods 07/23/2021Caffeine-Free Herbal Energy TeaTeaTaze, LLC1203 N Fieldcrest St Wichita, KS 67212teataze.com; facebook.com/teatazeteaNew Drug/MisbrandedWarning LetterFoods 07/23/2021Ignited Oolong Slimming TeaTeaTaze, LLC1203 N Fieldcrest St Wichita, KS 67212teataze.com; facebook.com/teatazeteaNew Drug/MisbrandedWarning LetterFoods 07/23/2021Power Puer Aged TeaTeaTaze, LLC1203 N Fieldcrest St Wichita, KS 67212teataze.com; facebook.com/teatazeteaNew Drug/MisbrandedWarning LetterFoods 07/23/2021Silver Tranquility White TeaTeaTaze, LLC1203 N Fieldcrest St Wichita, KS 67212teataze.com; facebook.com/teatazeteaNew Drug/MisbrandedWarning LetterFoods 07/22/2021“Regular Strength Nasadol CBD Nasal Spray”MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“Extra Strength Nasadol CBD Nasal Spray” MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“Pain Relief Roll-On”MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“CBD Oil Tincture” (500 mg and 1500 mg)MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“Sour Gummy Worms” (250 mg and 500 mg)MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“CBD Gummy Worms” (250 mg and 500 mg)MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“CBD Peach Rings” (250 mg and 500 mg)MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“Watermelon Slices” (250 mg, 500 mg, and 1000 mg)MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“CBD Gummy Bears” (500 mg and 1000 mg)MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“1,000mg Canine CBD Oil”MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021“CBD Dog Treats”MB Solutions, LLC/BioSpectrum CBD5980 Executive Dr. Suite A Madison, WI 53719biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/Unapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2021Miss SlimHISPalisades Park, NJmissslimusa.comUndeclared sibutramineRecallDrugs 07/20/2021Lion’s ManeBrilliant Enterprises LLC621 Main Street, Unit 182Gaylord, MI 49735levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushroomsUnapproved New Drugs/MisbrandedWarning LetterFoods 07/20/2021BoomChagaBrilliant Enterprises LLC621 Main Street, Unit 182Gaylord, MI 49735levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushroomsUnapproved New Drugs/MisbrandedWarning LetterFoods 07/20/2021CordaCexBrilliant Enterprises LLC621 Main Street, Unit 182Gaylord, MI 49735levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushroomsUnapproved New Drugs/MisbrandedWarning LetterFoods 07/20/2021LVL:MAXBrilliant Enterprises LLC621 Main Street, Unit 182Gaylord, MI 49735levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushroomsUnapproved New Drugs/MisbrandedWarning LetterFoods 07/20/2021“Germaphobe’s Delight Spray”Jordan’s Crossing Herbal Connections568 County Road 2307 Barnsdall, OK 74002jordanscrossing.net; youtube.com/watch?v=dWCJdjcjbfMUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 07/19/2021Alpha Male Plus Alpha Male Plusn/aalphamaleplus.usUndeclared tadalafilRecallDrugs 07/14/2021Diabetic Patch (aka Herbal Diabetic Patch)Healthy Livin' Solutions9169 W State St #628 Garden City, Idaho 83714healthylivin.solutionsNew DrugOnline Advisory LetterDrugs 07/09/2021X Rated Honey For MenVarious Distributorsn/aadameve.comUndeclared tadalafilPublic NotificationDrugs 07/09/2021“COVIGEN AG-1 Covid-19 Self Detection Kit”Biopolygen Corp.2207 East Carson St Carson, CA 90810biopolygen.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/09/2021“COVIDEX AB-1 Covid-19 Self Detection Kit”Biopolygen Corp.2207 East Carson St Carson, CA 90810biopolygen.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/09/2021“COVID-19 Antigen and Antibody Combo Set”Biopolygen Corp.2207 East Carson St Carson, CA 90810biopolygen.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/09/2021“Saliva Test Kit” USH Diagnostics, Inc./covidinstanttest.net3456 E. 155th St. Kansas City, MO 64147covidinstanttest.net; ushealthdiagnostics.com/; facebook.com/covid19instanttest; twitter.com/covidathometest; instagram.com/covid19instanttestAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/09/2021“Rapid 10 Minute Antigen Test”USH Diagnostics, Inc./covidinstanttest.net3456 E. 155th St. Kansas City, MO 64147covidinstanttest.net; ushealthdiagnostics.com/; facebook.com/covid19instanttest; twitter.com/covidathometest; instagram.com/covid19instanttestAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/09/2021“Rapid Dual Antibody Test” USH Diagnostics, Inc./covidinstanttest.net3456 E. 155th St. Kansas City, MO 64147covidinstanttest.net; ushealthdiagnostics.com/; facebook.com/covid19instanttest; twitter.com/covidathometest; instagram.com/covid19instanttestAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 07/08/2021Immune Booster3RD Day Nutraceuticals, LLC225 N Main St, Suite 404 Bristol, CT 060103rddaynutra.comNew Drug/MisbrandedWarning LetterFoods 07/08/2021Allergy Support3RD Day Nutraceuticals, LLC225 N Main St, Suite 404 Bristol, CT 060103rddaynutra.comNew Drug/MisbrandedWarning LetterFoods 07/08/2021Inflammatory Response Support3RD Day Nutraceuticals, LLC225 N Main St, Suite 404 Bristol, CT 060103rddaynutra.comNew Drug/MisbrandedWarning LetterFoods 07/08/2021Revive & Recover3RD Day Nutraceuticals, LLC225 N Main St, Suite 404 Bristol, CT 060103rddaynutra.comNew Drug/MisbrandedWarning LetterFoods 07/07/2021Halodine nasal and oral “sanitizer” product lines that include, Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral RinseHalodine, LLC111 NE 1st St, Suite 806 Miami, FL 33132-2506halodine.com; shop.halodine.com; twitter.com/TheHalodine; facebook.com/halodineUnapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 07/01/2021Genesis Ultra Slim GoldGenesis Nutrition Ultra Slim dba Genesis Ultra Slim10108 NW 77th StreetDoral, FL 33178fastweightlossgarcinia.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugsWarning Letter07/01/2021High Vitality Full Spectrum Liquid Multi-VitaminPhoenix Nutritionals, Inc.4727 Terrace Drive San Diego, CA 92116-2515phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/New Drug/MisbrandedWarning LetterFoods 07/01/2021High Vitality CapsPhoenix Nutritionals, Inc.4727 Terrace Drive San Diego, CA 92116-2515phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/New Drug/MisbrandedWarning LetterFoods 07/01/2021Best Cholesterol SupportPhoenix Nutritionals, Inc.4727 Terrace Drive San Diego, CA 92116-2515phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/New Drug/MisbrandedWarning LetterFoods 07/01/2021Blood Sugar SupportPhoenix Nutritionals, Inc.4727 Terrace Drive San Diego, CA 92116-2515phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/New Drug/MisbrandedWarning LetterFoods 07/01/2021Maximum Stress SupportPhoenix Nutritionals, Inc.4727 Terrace Drive San Diego, CA 92116-2515phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/New Drug/MisbrandedWarning LetterFoods 07/01/2021Complete Joint SupportPhoenix Nutritionals, Inc.4727 Terrace Drive San Diego, CA 92116-2515phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/New Drug/MisbrandedWarning LetterFoods 07/01/2021Natural Anti-Inflammatory SupportPhoenix Nutritionals, Inc.4727 Terrace Drive San Diego, CA 92116-2515phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/New Drug/MisbrandedWarning LetterFoods 07/01/2021Best Immune SupportPhoenix Nutritionals, Inc.4727 Terrace Drive San Diego, CA 92116-2515phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/New Drug/MisbrandedWarning LetterFoods 07/01/2021Altitude RXBiomedical Research Laboratories, LLC7590 Fay Ave Suite 202 La Jolla, CA 92037-4885brlsports.comNew Drug/MisbrandedWarning LetterFoods 07/01/2021Flexify Biomedical Research Laboratories, LLC7590 Fay Ave Suite 202 La Jolla, CA 92037-4885brlsports.comNew Drug/MisbrandedWarning LetterFoods 07/01/2021Calm LegsBiomedical Research Laboratories, LLC7590 Fay Ave Suite 202 La Jolla, CA 92037-4885nativeorigins.com; brlscience.com; facebook.com/mynativeoriginsNew Drug/MisbrandedWarning LetterFoods 07/01/2021Collagen PeptidesBiomedical Research Laboratories, LLC7590 Fay Ave Suite 202 La Jolla, CA 92037-4885nativeorigins.com; brlscience.com; facebook.com/mynativeoriginsNew Drug/MisbrandedWarning LetterFoods 07/01/2021ProhemiaBiomedical Research Laboratories, LLC7590 Fay Ave Suite 202 La Jolla, CA 92037-4885nativeorigins.com; brlscience.com; facebook.com/mynativeoriginsNew Drug/MisbrandedWarning LetterFoods 07/01/2021TrimmunityBiomedical Research Laboratories, LLC7590 Fay Ave Suite 202 La Jolla, CA 92037-4885nativeorigins.com; brlscience.com; facebook.com/mynativeoriginsNew Drug/MisbrandedWarning LetterFoods 06/30/2021365 SKINNY High IntensityJe Dois Lavoir LLCn/ajedoisavoir2020.com; facebook.com/jdl2020; instagram.com/j_d_l2020Undeclared sibutraminePublic NotificationDrugs

Recall

Warning Letter

06/23/2021ProbioticXL Great Healthworks, Inc.4150 SW 28th Way Fort Lauderdale, FL 33312-5201greathealthworks.comUnapproved New Drugs/MisbrandedWarning LetterFoods 06/23/2021OmegaXLGreat Healthworks, Inc.4150 SW 28th Way Fort Lauderdale, FL 33312-5201greathealthworks.comUnapproved New Drugs/MisbrandedWarning LetterFoods 06/22/2021Immune BuilderPacific Center of Health/Pacific Center of Health & Acupuncture8555 Aero Dr. Suite 107 San Diego, CA 92123pacificcenterofhealth.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 06/22/2021High Risk Environment Pack- NO SYMPTOMSPacific Center of Health/Pacific Center of Health & Acupuncture8555 Aero Dr. Suite 107 San Diego, CA 92123pacificcenterofhealth.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 06/22/2021Anti-Viral Herbal FormulaPacific Center of Health/Pacific Center of Health & Acupuncture8555 Aero Dr. Suite 107 San Diego, CA 92123pacificcenterofhealth.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 06/22/2021Anti-Viral Herbal Pack – ACUTE ILLINESSPacific Center of Health/Pacific Center of Health & Acupuncture8555 Aero Dr. Suite 107 San Diego, CA 92123pacificcenterofhealth.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 06/22/2021Kitchen SinkPacific Center of Health/Pacific Center of Health & Acupuncture8555 Aero Dr. Suite 107 San Diego, CA 92123pacificcenterofhealth.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 06/22/2021Lung Formula Dry CoughPacific Center of Health/Pacific Center of Health & Acupuncture8555 Aero Dr. Suite 107 San Diego, CA 92123pacificcenterofhealth.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 06/22/2021Lung Formula Wet CoughPacific Center of Health/Pacific Center of Health & Acupuncture8555 Aero Dr. Suite 107 San Diego, CA 92123pacificcenterofhealth.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 06/22/2021Colloidal SilverPacific Center of Health/Pacific Center of Health & Acupuncture8555 Aero Dr. Suite 107 San Diego, CA 92123pacificcenterofhealth.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 06/22/2021Post COVID-19 RecoveryPacific Center of Health/Pacific Center of Health & Acupuncture8555 Aero Dr. Suite 107 San Diego, CA 92123pacificcenterofhealth.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 06/10/2021Super TonicNatural Hope Herbals, LLC670 Phillips Road Millersburg, PA 17061-9044naturalhopeherbals.comNew Drug/MisbrandedWarning LetterFoods 06/10/2021Respiratory AidNatural Hope Herbals, LLC670 Phillips Road Millersburg, PA 17061-9044naturalhopeherbals.comNew Drug/MisbrandedWarning LetterFoods 06/10/2021Wild Cherry Honey SyrupNatural Hope Herbals, LLC670 Phillips Road Millersburg, PA 17061-9044naturalhopeherbals.comNew Drug/MisbrandedWarning LetterFoods 06/10/2021Ivy OakyNatural Hope Herbals, LLC670 Phillips Road Millersburg, PA 17061-9044naturalhopeherbals.comNew Drug/MisbrandedWarning LetterFoods 06/10/2021Jewelweed Spray Combo PackNatural Hope Herbals, LLC670 Phillips Road Millersburg, PA 17061-9044naturalhopeherbals.comNew Drug/MisbrandedWarning LetterFoods 06/10/2021Jewelweed SprayNatural Hope Herbals, LLC670 Phillips Road Millersburg, PA 17061-9044naturalhopeherbals.comNew Drug/MisbrandedWarning LetterFoods 06/10/2021Prostate HealthNatural Hope Herbals, LLC670 Phillips Road Millersburg, PA 17061-9044naturalhopeherbals.comNew Drug/MisbrandedWarning LetterFoods 06/10/2021Kidney/BladderNatural Hope Herbals, LLC670 Phillips Road Millersburg, PA 17061-9044naturalhopeherbals.comNew Drug/MisbrandedWarning LetterFoods 06/10/2021Bone & Tissue ConnectNatural Hope Herbals, LLC670 Phillips Road Millersburg, PA 17061-9044naturalhopeherbals.comNew Drug/MisbrandedWarning LetterFoods 06/10/2021SARS-CoV-2 Antigen Rapid Qualitative TestInnova Medical Group, Inc.800 E. Colorado Blvd., Suite 288 Pasadena, CA 91101n/aUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 06/07/2021Travel Care ProbioticFlora Inc805 E. Badger Rd. Lynden, WA 98264-9502florahealth.com/us; pinterest.com/florahealth/New Drug/MisbrandedWarning LetterFoods 06/07/2021Sleep•EssenceFlora Inc805 E. Badger Rd. Lynden, WA 98264-9502florahealth.com/us; pinterest.com/florahealth/New Drug/MisbrandedWarning LetterFoods 06/07/2021Cardio•EssenceFlora Inc805 E. Badger Rd. Lynden, WA 98264-9502florahealth.com/us; pinterest.com/florahealth/New Drug/MisbrandedWarning LetterFoods 06/07/2021Grape Seed Extract PlusFlora Inc805 E. Badger Rd. Lynden, WA 98264-9502florahealth.com/us; pinterest.com/florahealth/New Drug/MisbrandedWarning LetterFoods 06/07/2021Elderberry+, Elderberry CrystalsFlora Inc805 E. Badger Rd. Lynden, WA 98264-9502florahealth.com/us; pinterest.com/florahealth/New Drug/MisbrandedWarning LetterFoods 06/07/2021Flor•EssenceFlora Inc805 E. Badger Rd. Lynden, WA 98264-9502florahealth.com/us; pinterest.com/florahealth/New Drug/MisbrandedWarning LetterFoods 06/07/2021Hydro-Therm Pumpkin OilFlora Inc805 E. Badger Rd. Lynden, WA 98264-9502florahealth.com/us; pinterest.com/florahealth/New Drug/MisbrandedWarning LetterFoods 06/07/2021Pumpkin OilFlora Inc805 E. Badger Rd. Lynden, WA 98264-9502florahealth.com/us; pinterest.com/florahealth/New Drug/MisbrandedWarning LetterFoods 06/07/2021Mãnuka HoneyFlora Inc805 E. Badger Rd. Lynden, WA 98264-9502florahealth.com/us; pinterest.com/florahealth/New Drug/MisbrandedWarning LetterFoods 06/04/2021Miss SlimVarious Distributorsn/aamazon.comUndeclared sibutraminePublic NotificationDrugs 06/04/2021Adam’s Secret Extra Strength 2000Various Distributorsn/aamazon.comUndeclared tadalafilPublic NotificationDrugs 05/27/2021BerberineFresh Nutrition Inc23860 Nicole Way Yorba Linda, CA 92887-5626fresh-nutrition.comUnapproved New Drugs/MisbrandedWarning LetterFoods 05/27/2021EchinaceaFresh Nutrition Inc23860 Nicole Way Yorba Linda, CA 92887-5626fresh-nutrition.comUnapproved New Drugs/MisbrandedWarning LetterFoods 05/27/2021European ElderberryFresh Nutrition Inc23860 Nicole Way Yorba Linda, CA 92887-5626fresh-nutrition.comUnapproved New Drugs/MisbrandedWarning LetterFoods 05/27/2021Milk ThistleFresh Nutrition Inc23860 Nicole Way Yorba Linda, CA 92887-5626fresh-nutrition.comUnapproved New Drugs/MisbrandedWarning LetterFoods 05/27/2021Lion’s Mane MushroomFresh Nutrition Inc23860 Nicole Way Yorba Linda, CA 92887-5626fresh-nutrition.comUnapproved New Drugs/MisbrandedWarning LetterFoods 05/27/2021Turmeric CurcuminFresh Nutrition Inc23860 Nicole Way Yorba Linda, CA 92887-5626fresh-nutrition.comUnapproved New Drugs/MisbrandedWarning LetterFoods 05/27/2021Fish OilFresh Nutrition Inc23860 Nicole Way Yorba Linda, CA 92887-5626fresh-nutrition.comUnapproved New Drugs/MisbrandedWarning LetterFoods 05/27/2021Green Lipped MusselsFresh Nutrition Inc23860 Nicole Way Yorba Linda, CA 92887-5626fresh-nutrition.comUnapproved New Drugs/MisbrandedWarning LetterFoods 05/27/2021Various chlorine dioxide products, including “OCLO 3000E”OCLO LLC/OCLO Nanotechnology Science220 SW 9th Ave, #506 Hallandale, FL 33009dioxidodecloro.us; facebook.com/Hallandale.Beach.2018/; oclo.ecrater.com/index.phpUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 05/26/2021Super Naturals brand IBSolutionJLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health1309 ½ S. Roxbury Dr. Los Angeles, CA 90035supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsreliefNew Drug/MisbrandedWarning LetterFoods 05/26/2021Premium ProbioticJLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health1309 ½ S. Roxbury Dr. Los Angeles, CA 90035supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsreliefNew Drug/MisbrandedWarning LetterFoods 05/26/2021Sleep SolutionJLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health1309 ½ S. Roxbury Dr. Los Angeles, CA 90035supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsreliefNew Drug/MisbrandedWarning LetterFoods 05/26/2021Joint SolutionJLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health1309 ½ S. Roxbury Dr. Los Angeles, CA 90035supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsreliefNew Drug/MisbrandedWarning LetterFoods 05/26/2021Ultra Omega Fish OilJLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health1309 ½ S. Roxbury Dr. Los Angeles, CA 90035supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsreliefNew Drug/MisbrandedWarning LetterFoods 05/24/2021Brazilian Propolis ExtractBeauty & Spa Concepts, DBA Beenefits10765 Southwest 108th Ave. #308 Miami, FL 33176beenefits.com; instagram.com/beenefits/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 05/24/2021CoronaBoxEverything Health LLC1445 293rd Ave NE Carnation, WA 98014ssnaturalhealing.com; facebook.com/ssdallastx/; instagram.com/tamikamoseley/; twitter.com/sicklesolutionUnapproved and Misbranded Products Related to Coronavirus Disease 2019(COVID-19)Warning LetterFoods 05/20/2021“NaturaCure”NS Products, Inc.11721 State Ave Marysville, WA 98271naturacure.netNew Drug/MisbrandedWarning LetterFoods 05/20/2021“OVOENERGEN™ CoenzymeQ10”Fertility Nutraceuticals LLC21 E 69th St New York, NY 10021fertilitynutraceuticals.com; fertilitysupplementstore.comNew Drug/MisbrandedWarning LetterFoods 05/20/2021“FERTINATAL® DHEA”Fertility Nutraceuticals LLC21 E 69th St New York, NY 10021fertilitynutraceuticals.com; fertilitysupplementstore.comNew Drug/MisbrandedWarning LetterFoods 05/20/2021“CONFLAM- Forte™”Fertility Nutraceuticals LLC21 E 69th St New York, NY 10021fertilitynutraceuticals.com; fertilitysupplementstore.comNew Drug/MisbrandedWarning LetterFoods 05/20/2021“CONCEPTION MEN Male Fertility”EU Natural Inc.2654 W Horizon Ridge Pkwy Ste B5-93 Henderson, NV 89052store.eunatural.com; instagram.com/eunatural/New Drug/MisbrandedWarning LetterFoods 05/20/2021“CONCEPTION Female Fertility Prenatal”EU Natural Inc.2654 W Horizon Ridge Pkwy Ste B5-93 Henderson, NV 89052store.eunatural.com; instagram.com/eunatural/New Drug/MisbrandedWarning LetterFoods 05/20/2021“ConceiveEasy”LeRoche Benicoeur dba ConceiveEasy1130 Fremont Blvd #301 Seaside, CA 93955conceiveeasy.comNew Drug/MisbrandedWarning LetterFoods 05/20/2021“FertilHerb for Womenr”Sal Nature LLC/FertilHerb1621 Central Ave Cheyenne, WY 82001-4531fertilherb.comNew Drug/MisbrandedWarning LetterFoods 05/19/2021“BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug”BGP, LLC2118 Wilshire Blvd Santa Monica, CA 90403biocence.com; facebook.com/Biocence; instagram.com/biocenceUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 05/12/2021Lipodrene w/25mg Ephedra Extract Dietary SupplementHi-Tech Pharmaceuticals. IncNorcross, GAn/aPresence of 1,4-dimethylamylamine (DMAA)RecallFoods 05/10/2021Collagen Endurance PlusGreat Lakes Gelatin Company253 Commerce Dr., Ste 101 Grayslake, IL 60030greatlakesgelatin.com facebook.com/greatlakesgel/; pinterest.com/greatlakesgel/New Drug/MisbrandedWarning LetterFoods 05/10/2021Keto Collagen + MCTGreat Lakes Gelatin Company253 Commerce Dr., Ste 101 Grayslake, IL 60030greatlakesgelatin.com facebook.com/greatlakesgel/; pinterest.com/greatlakesgel/New Drug/MisbrandedWarning LetterFoods 05/10/2021Collagen Hydrolysate (10 oz unflavored and vanilla, mixed berry, lemon + lime, apple + cucumber, chocolate, and chai flavors, 16 oz unflavored, Convenience Pack (20 count unflavored), 8lb unflavored)Great Lakes Gelatin Company253 Commerce Dr., Ste 101 Grayslake, IL 60030greatlakesgelatin.com facebook.com/greatlakesgel/; pinterest.com/greatlakesgel/New Drug/MisbrandedWarning LetterFoods 05/06/2021DISINFECT™ & SHIELD HAND SANITIZER non-alcohol based hand sanitizer productsDisinfect & Shield1616 Fountain View Drive Houston, TX 77057disinfectandshield.comUnapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 05/06/2021Non-alcohol based hand sanitizer productsCovalon Technologies Inc.1660 Tech Avenue, Unit 5 Mississauga ON L4W 5S7 Canadacovaguard.com; instagram.com/covaguard/; facebook.com/covaguard/Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 05/04/2021GenBody COVID-19 IgM/IgG testBaltimore Beauty Security Square Mall6901 Security Square Blvd. #343 Baltimore, MD 21244n/aAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 05/04/2021GenBody COVID-19 Ag testBaltimore Beauty Security Square Mall6901 Security Square Blvd. #343 Baltimore, MD 21244n/aAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 04/29/2021Tummy Tuck MaxVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 04/29/2021Enerup PremiumVarious Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 04/29/2021ErectMaxVarious Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 04/29/2021Vital SexVarious Distributors Examination of imported goodsUndeclared sildenafilPublic NotificationDrugs 04/29/2021Iodine DetoxifiedCrown Wellness, Inc.421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138crownwellness.com New Drug/MisbrandedWarning LetterFoods 04/29/2021Karma CleanseCrown Wellness, Inc.421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138crownwellness.com New Drug/MisbrandedWarning LetterFoods 04/29/2021E3 Digestive Enzymes SupremeCrown Wellness, Inc.421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138crownwellness.com New Drug/MisbrandedWarning LetterFoods 04/29/2021Diatomaceous Earth Powder (DE)Crown Wellness, Inc.421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138crownwellness.com New Drug/MisbrandedWarning LetterFoods 04/29/2021E3 Renew Me/B.G. Blue Green AlgaeCrown Wellness, Inc.421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138crownwellness.com New Drug/MisbrandedWarning LetterFoods 04/29/2021Clinic’s Choice CLO2Crown Wellness, Inc.421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138crownwellness.com New Drug/MisbrandedWarning LetterFoods 04/28/2021Herpes Protocol Ultimate KitThe Underground CureP.O. Box 1111 Snellville, GA 30078theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGCNew DrugOnline Advisory LetterFoods; Drugs 04/28/2021Herpes Protocol Vitamin KitThe Underground CureP.O. Box 1111 Snellville, GA 30078theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGCNew DrugOnline Advisory LetterFoods; Drugs 04/28/2021Olive Leaf ExtractThe Underground CureP.O. Box 1111 Snellville, GA 30078theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGCNew DrugOnline Advisory LetterFoods; Drugs 04/28/2021DMSO Liquid 70/30The Underground CureP.O. Box 1111 Snellville, GA 30078theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGCNew DrugOnline Advisory LetterFoods; Drugs 04/28/2021Gentiana ComplexThe Underground CureP.O. Box 1111 Snellville, GA 30078theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGCNew DrugOnline Advisory LetterFoods; Drugs 04/27/2021“HM-FORMULA”NeuroHydrate LLC4637 Main St, Unit 5 Bridgeport, CT 06606-1838neurohydrate.com/New Drug/MisbrandedWarning LetterFoods 04/21/2021Pixie Dust MagnesiumDRF LLCUnited Statesdoctorfarrah.com; drfarrah.online New Drug/MisbrandedWarning LetterFoods 04/21/2021Mega-Dose Vitamin CDRF LLCUnited Statesdoctorfarrah.com; drfarrah.online New Drug/MisbrandedWarning LetterFoods 04/21/2021Boston CDRF LLCUnited Statesdoctorfarrah.com; drfarrah.online New Drug/MisbrandedWarning LetterFoods 04/21/2021“Red 65”North American Hirudin Biotech Products Inc.2531 Broadway, Suite A Everett, WA 98201ushirudin.com/; naturalhirudin.com/; buyred65.com/New Drug/MisbrandedWarning LetterFoods 04/21/2021“Hirudin” North American Hirudin Biotech Products Inc.2531 Broadway, Suite A Everett, WA 98201ushirudin.com/; naturalhirudin.com/; buyred65.com/New Drug/MisbrandedWarning LetterFoods 04/15/2021Balanced KollagenMolecular BioLife International, Inc.200 W 16th St Bldg B Sheldon, IA 51201-2008molecularbiolife.comNew Drug/MisbrandedWarning LetterFoods 04/15/2021Shark 2 Collagen Molecular BioLife International, Inc.200 W 16th St Bldg B Sheldon, IA 51201-2008molecularbiolife.comNew Drug/MisbrandedWarning LetterFoods 04/13/2021“COVID-19 Formula”Trinity Natural Health & Pain Management, Inc.1100 NE 125th Street, Suite #203A North Miami, FL 33161trinity-naturalhealth.com/; facebook.com/TrinityNaturalSupplementsUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 04/13/2021Apple Cider Vinegar CapsulesOrphic Nutrition2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_blnNew Drug/MisbrandedWarning LetterFoods 04/13/2021Ashwagandha CapsulesOrphic Nutrition2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_blnNew Drug/MisbrandedWarning LetterFoods 04/13/2021Garcinia Cambogia CapsulesOrphic Nutrition2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_blnNew Drug/MisbrandedWarning LetterFoods 04/13/2021Premium Collagen Peptides CapsulesOrphic Nutrition2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_blnNew Drug/MisbrandedWarning LetterFoods 04/13/2021Elderberry GummiesOrphic Nutrition2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_blnNew Drug/MisbrandedWarning LetterFoods 04/13/2021Omega 3 Fish Oil SoftgelsOrphic Nutrition2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_blnNew Drug/MisbrandedWarning LetterFoods 04/13/2021Turmeric Curcumin with Bioperin CapsulesOrphic Nutrition2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_blnNew Drug/MisbrandedWarning LetterFoods 04/13/2021“Covid-19 Test Kit”Anytime COVID Test LLC6615 West Boynton Beach Blvd., #181 Boynton Beach, FL 33437anytimecovidtest.com; mycovidtester.com; gotcovidtests.com; covidtestyou.com buymycovidtest.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 04/08/2021Alterra Sili-Mer G5Groupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021AnemiaGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021Cancer (Piptopet)Groupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021Cancer (Specific Remedy)Groupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021Cataract-LGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021FractureGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021HeartGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021Heart MurmurGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021HeartwormGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021Hip DysplasiaGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021ParvopetGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021SeizurepetGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021ThyroidpetGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021Virus Defense Kit, which includes your Immunopet, Silverpet, and CordycepsGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/08/2021White Blood CellsGroupe Cyrenne Inc. dba HomeoAnimal1205 Des Chataigniers Quebec QC G3G 3C4 Canadahomeoanimal.com; facebook.com/homeoanimalUnapproved New Animal Drug ProductsWarning LetterVeterinary 04/07/2021Silver Soul Immune SupportAllure Imports405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783facedoctor.ca; vitalityc60.com allureimports.com facebook.com/facedoctorca/; facebook.com/vitalityc60; instagram.com/facedoctor.ca/; twitter.com/FaceDoctorRx/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs, Veterinary 04/07/2021Silver Soul Body Spray Allure Imports405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783facedoctor.ca; vitalityc60.com allureimports.com facebook.com/facedoctorca/; facebook.com/vitalityc60; instagram.com/facedoctor.ca/; twitter.com/FaceDoctorRx/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs, Veterinary 04/07/2021Vitality C60Allure Imports405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783facedoctor.ca; vitalityc60.com allureimports.com facebook.com/facedoctorca/; facebook.com/vitalityc60; instagram.com/facedoctor.ca/; twitter.com/FaceDoctorRx/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs, Veterinary 04/07/2021Puriton topical skin productsAbout Mineral3063 W. Chapman Ave., #6301 Orange, CA 92868aboutmineral.com; facebook.com/aboutmineral; instagram.com/about_mineral/;Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 04/07/2021ColoxUnived Inc16491 Scientific Way Irvine, CA 92618unived.us/; amazon.comNew Drug/MisbrandedWarning LetterFoods 04/07/2021CalDvegUnived Inc16491 Scientific Way Irvine, CA 92618unived.us/; amazon.comNew Drug/MisbrandedWarning LetterFoods 04/07/2021B12+D3Unived Inc16491 Scientific Way Irvine, CA 92618unived.us/; amazon.comNew Drug/MisbrandedWarning LetterFoods 04/07/2021D3+K2-7Unived Inc16491 Scientific Way Irvine, CA 92618unived.us/; amazon.comNew Drug/MisbrandedWarning LetterFoods 04/06/2021“Rapid COVID-19 Antigen Self Test Kit”Sethi Laboratories17290 Preston Road Suite 300 Dallas, TX 75252sethilaboratories.com; facebook.com/sethilabs; instagram.com/p/CGC8yKEHXZO; twitter.com/SethiLabsUSAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 04/06/2021“Rapid COVID-19 Antibody Self Test Kit”Sethi Laboratories17290 Preston Road Suite 300 Dallas, TX 75252sethilaboratories.com; facebook.com/sethilabs; instagram.com/p/CGC8yKEHXZO; twitter.com/SethiLabsUSAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 04/01/2021Purity Essential Oil Blend productsNatural Adventure, LLC13765 SW 32nd Street Miramar, FL 33027mynaturaladventure.com; facebook.com/MyNatAdventure; instagram.com/mynatadventure/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 04/01/2021Purity Sanitizer with 70% Alcohol Natural Adventure, LLC13765 SW 32nd Street Miramar, FL 33027mynaturaladventure.com; facebook.com/MyNatAdventure; instagram.com/mynatadventure/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 03/30/2021Immune Bio Green CellImmune & Genetics Protocols, LLC1655 SW 63rd ST RD Ocala, FL 34476biogreencell.com; facebook.com/BioGreenCell/New Drug/MisbrandedWarning LetterDevices 03/29/2021Formula INature's Pharmacy, LLC1565 195th Avenue Bloomer, WI 54724naturespharmacyllc.comNew DrugOnline Advisory LetterFoods; Drugs 03/29/2021Formula IINature's Pharmacy, LLC1565 195th Avenue Bloomer, WI 54724naturespharmacyllc.comNew DrugOnline Advisory LetterFoods; Drugs 03/29/2021Formula IIINature's Pharmacy, LLC1565 195th Avenue Bloomer, WI 54724naturespharmacyllc.comNew DrugOnline Advisory LetterFoods; Drugs 03/29/2021Formula IVNature's Pharmacy, LLC1565 195th Avenue Bloomer, WI 54724naturespharmacyllc.comNew DrugOnline Advisory LetterFoods; Drugs 03/29/2021Formula VNature's Pharmacy, LLC1565 195th Avenue Bloomer, WI 54724naturespharmacyllc.comNew DrugOnline Advisory LetterFoods; Drugs 03/29/2021Magnesium Transdermal PatchesBetter Supplement Solutions Inc. dba XanFree105 Overton St Deer Park, NY 11729xanfree.com; facebook.com/getxanfreeNew DrugOnline Advisory LetterFoods; Drugs 03/29/2021Tranquil BlendBetter Supplement Solutions Inc. dba XanFree105 Overton St Deer Park, NY 11729xanfree.com; facebook.com/getxanfreeNew DrugOnline Advisory LetterFoods; Drugs 03/29/2021Tranquil Blend + Magnesium Transdermal ComboBetter Supplement Solutions Inc. dba XanFree105 Overton St Deer Park, NY 11729xanfree.com; facebook.com/getxanfreeNew DrugOnline Advisory LetterFoods; Drugs 03/29/2021Yin-Yang Essence Men PowerVarious Distributorsn/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 03/29/2021Furious X 1350Various Distributorsn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 03/29/2021Zing PlusVarious Distributorsn/aamazon.comUndeclared sildenafilPublic NotificationDrugs 03/25/2021“Akcutest COVID-19 Antibody Test” Ikcon Investments, Inc dba Ikcon Medical14653 Caminito Lazanja San Diego, CA 92127ikconmedical.com; akcutestshop.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 03/25/2021“Lumigenik COVID-19 Antigen Rapid Test”Ikcon Investments, Inc dba Ikcon Medical14653 Caminito Lazanja San Diego, CA 92127ikconmedical.com; akcutestshop.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 03/24/2021 “COVID-19 IgM/IgG Rapid Test”Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs424 S. Roadway New Orleans, LA 70124tmtestkits.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 03/19/2021Lipotriad Vision Support PlusLipotriad LLC5 Sentry Parkway East Suite 210 Blue Bell, PA 19422lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/LipotriadNew Drug/MisbrandedWarning LetterFoods 03/19/2021Lipotriad Dry EyeLipotriad LLC5 Sentry Parkway East Suite 210 Blue Bell, PA 19422lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/LipotriadNew Drug/MisbrandedWarning LetterFoods 03/19/2021Lipotriad Adult 50+Lipotriad LLC5 Sentry Parkway East Suite 210 Blue Bell, PA 19422lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/LipotriadNew Drug/MisbrandedWarning LetterFoods 03/19/2021Lipotriad VisionaryLipotriad LLC5 Sentry Parkway East Suite 210 Blue Bell, PA 19422lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/LipotriadNew Drug/MisbrandedWarning LetterFoods 03/18/2021“Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold)”Block Scientific22 Sawgrass Drive Bellport, NY 11713blockscientificstore.com Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 03/18/2021“QUIKPACII COVID-19 ANTIBODY TEST KIT”Block Scientific22 Sawgrass Drive Bellport, NY 11713blockscientificstore.com Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 03/18/2021"Magnesium Oil Spray"BioLyte Laboratories, LLC310 Northern Dr. NW, Grand Rapids, MI 49534N/ACGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 03/18/2021"Pain Relief Cream"BioLyte Laboratories, LLC310 Northern Dr. NW Grand Rapids, MI 49534N/ACGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 03/18/2021"Therapeutic Pain Gel"BioLyte Laboratories, LLC310 Northern Dr. NW, Grand Rapids, MI 49534N/ACGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 03/18/2021"Silver Liquid Supplement"BioLyte Laboratories, LLC310 Northern Dr. NW, Grand Rapids, MI 49534N/ACGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 03/18/2021"Silver Gel with Aloe"BioLyte Laboratories, LLC310 Northern Dr. NW, Grand Rapids, MI 49534N/ACGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 03/18/2021"Silver Gel"BioLyte Laboratories, LLC310 Northern Dr. NW, Grand Rapids, MI 49534N/ACGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 03/16/2021FucoidanAnna Health, LLC9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550annahealth.comNew Drug/MisbrandedWarning LetterFoods 03/16/2021Prostate HealthAnna Health, LLC9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550annahealth.comNew Drug/MisbrandedWarning LetterFoods 03/16/2021Children Liquid VitaminsAnna Health, LLC9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550annahealth.comNew Drug/MisbrandedWarning LetterFoods 03/16/2021Immune HealthAnna Health, LLC9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550annahealth.comNew Drug/MisbrandedWarning LetterFoods 03/16/2021FucoidanDuoc Thao Tre Xanh, LLC9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550duocthaotrexanh.comNew Drug/MisbrandedWarning LetterFoods 03/16/2021Papaya Leaf Extract Duoc Thao Tre Xanh, LLC9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550duocthaotrexanh.comNew Drug/MisbrandedWarning LetterFoods 03/16/2021Ganoderma Lucidum Red Reishi MushroomDuoc Thao Tre Xanh, LLC9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550duocthaotrexanh.comNew Drug/MisbrandedWarning LetterFoods 03/16/2021Immune HealthDuoc Thao Tre Xanh, LLC9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550duocthaotrexanh.comNew Drug/MisbrandedWarning LetterFoods 03/15/2021“ELIXICURE PAIN RELIEF with CBD” productsHonest Globe, Inc.3605 West Macarthur Boulevard, Suite 701 Santa Ana, CA 92704-6845N/ACGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 03/12/2021“ROSE FREQUENCY TONGUE TINCTURE”Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials351 NW Pleasant View Dr, Grants Pass OR 37526ravenscroftescentials.com; instagram.com/ravenscroftoilsUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 03/12/2021"ELEVATION OF MIND AROMAMIST” Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials351 NW Pleasant View Dr, Grants Pass OR 37526ravenscroftescentials.com; instagram.com/ravenscroftoilsUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 03/12/2021“HEALER’s CHAI AROMATEA & BREATH DROPS”Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials351 NW Pleasant View Dr, Grants Pass OR 37526ravenscroftescentials.com; instagram.com/ravenscroftoilsUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 03/12/2021“AIR PURIFY AROMAMIST”Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials351 NW Pleasant View Dr, Grants Pass OR 37526ravenscroftescentials.com; instagram.com/ravenscroftoilsUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 03/05/20212 Own The Knight Silver 4000Various Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 03/05/2021Rhino SE7EN2Various Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 03/05/2021Stiff RoxVarious Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 03/05/2021Titanium 18KVarious Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 03/05/2021"IoWipe," Hand wipe productCAMA Wellness Center/IodoRios Company, LLC6782 Germantown Ave. Philadelphia, PA 19119cp.camacenter.com; facebook.com/IoWipeUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 03/01/2021"Balance CBD Drops"Cannafyl7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 03/01/2021"Relief CBD Drops"Cannafyl7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 03/01/2021"Relax CBD Drops"Cannafyl7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 03/01/2021"Relief CBD Salve"Cannafyl7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 03/01/2021“Immunoral”Ageless Global, LLC2722 S. West Temple, Salt Lake City, UT 84115agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 03/01/2021“Immune Plus”Ageless Global, LLC2722 S. West Temple, Salt Lake City, UT 84115agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 03/01/2021“MD Immune Support Spray”Ageless Global, LLC2722 S. West Temple, Salt Lake City, UT 84115agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 03/01/2021“MD CVK-365 Mouth Spray”Ageless Global, LLC2722 S. West Temple, Salt Lake City, UT 84115agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 02/26/2021Vy & TeaQikmoov, LLCn/avyteaus.comUndeclared sibutraminePublic NotificationDrugs 02/26/2021“LUNGENE [sic] SARS-CoV-V-2 Covid-19 IgG/IgM Rapid Antibody Test Cassette to Detect Previous Corona Virus Infections”Orvic dba Webstore-USA15922 Strathern St #16, Van Nuys, CA 91406facemaskandppestore.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 02/24/2021Alpha Male Plus (also referred to as Alpha Male+)Various Distributorsn/aalphamaleplus.usUndelclared tadalafilPublic NotificationDrugs 02/18/2021MindSoothe DropsNative Remedies dba Silver Star Brands250 City Center, Oshkosh, WI 54906nativeremedies.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021MindSoothe CapsulesNative Remedies dba Silver Star Brands250 City Center, Oshkosh, WI 54906nativeremedies.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021Mood SupportMountain Peak Nutritionals9953 SW Arctic Dr., Beaverton, OR 97005mountainpeaknutritionals.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021Natural Anxiety & Depression ReliefWholesome Wellness6804 NE 79th Court, Portland, OR 97218wholesome-wellness.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021Mood Boosting ProbioticLifted Naturals1101 Mulberry St, A2 Suite 10, Kansas City, MO 64101liftednaturals.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021“Enlifta Mood Elevator”Enlifta, LLC16372 Page St., Omaha, NE 68118enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/New Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021“Enlifta Anxiety”Enlifta, LLC16372 Page St., Omaha, NE 68118enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/New Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021St. John’s Wort Blossom Nature, LLC1193 Elederberry Circle, Folsom, CA 95630blossom-nature.com; amazon.com/Supplement-National-Antidepressant-Support-Provides-Relief-120/dp/B082TTLJGPNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021Full Spectrum™ St. John's Wort ExtractProHealth Inc.555 Maple St, Carpinteria, CA 93013prohealth.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021Dr. Garber's Depression ReliefDr. Garber’s Natural Solutions2607 2nd St #1, Santa Monica, CA 90405drgarbers.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021Inositol 100% Pure Free FormFDC Nutrition Inc.2313 East Philadelphia Street Ste L, Ontario, CAfdcnutrition.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021Sleep Sana “Sleep Drops”SANA Group LLC1200 E. Woodhurst S-200, Springfield, MO 65804sleepsana.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021Sleep Sana “Sleep Shots” SANA Group LLC1200 E. Woodhurst S-200, Springfield, MO 65804sleepsana.comNew Drug/MisbrandedWarning LetterFoodsNews Release02/18/2021“Liposomal Vitamin C”Mercola.com, LLC125 SW 3rd Place, Suite 205, Cape Coral, FL 33991mercola.com; mercolamarket.com; twitter.com/mercolaUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 02/18/2021“Liposomal Vitamin D3” Mercola.com, LLC125 SW 3rd Place, Suite 205, Cape Coral, FL 33991mercola.com; mercolamarket.com; twitter.com/mercolaUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 02/18/2021“Quercetin and Pterostilbene Advanced”Mercola.com, LLC125 SW 3rd Place, Suite 205, Cape Coral, FL 33991mercola.com; mercolamarket.com; twitter.com/mercolaUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 02/18/2021Earth Tea Extra StrengthB4B Corp.40 Remsen Ave, Brooklyn, NY 11212b4bcorp.com; twitter.com/b4bcorpusaUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 02/18/2021The Prevention 12 Pak (Coronavirus Prevention 12 Pak), consists of the products SOUL, CORE, Cellular Detox, Turb-O2, Vitamin C (Anti-Oxidant Assist), Vitamin D3 (Light Assist), Glutathione, Selenium, Zinc, Vitamin A, Melatonin, and Iod Assist (Iodine)SafaLab, Inc.317 Cascade Ave., Langley, WA 98260safalab.com; weeksmd.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 02/16/2021“COVID-Aid Tincture”Dr. Paul's Lab9559 County Road Y, Mazomanie, WI 53560drpaulslab.net; drsarahsessentials.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 02/11/2021“BioCBD+ Total Body Care”Evolved Ayurvedic Discoveries, Inc./BioCBDPlus315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plusFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 02/11/2021“BioCBD+ Topical Oil Muscle & Joint Support” Evolved Ayurvedic Discoveries, Inc./BioCBDPlus315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plusFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 02/11/2021“BioCBD+ Peace Vape”Evolved Ayurvedic Discoveries, Inc./BioCBDPlus315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plusFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 02/02/2021“OsteoBLAST®”Clarke Pharmaceutical Manufacturing, Inc.17448 Highway 3 Ste. 141, Webster, TX 77598clarkepharmaceuticals.comUnapproved New Drugs/MisbrandedWarning LetterDrugs 02/02/2021“Cell Block #19”Clarke Pharmaceutical Manufacturing, Inc.17448 Highway 3 Ste. 141, Webster, TX 77598clarkepharmaceuticals.comUnapproved New Drugs/MisbrandedWarning LetterDrugs 02/02/2021“High Potency Vitamin D3”Clarke Pharmaceutical Manufacturing, Inc.17448 Highway 3 Ste. 141, Webster, TX 77598clarkepharmaceuticals.comUnapproved New Drugs/MisbrandedWarning LetterDrugs 02/02/2021“Neupanex®” Clarke Pharmaceutical Manufacturing, Inc.17448 Highway 3 Ste. 141, Webster, TX 77598clarkepharmaceuticals.comUnapproved New Drugs/MisbrandedWarning LetterDrugs 02/02/2021“Natural Progesterone Skin Cream”Clarke Pharmaceutical Manufacturing, Inc.17448 Highway 3 Ste. 141, Webster, TX 77598clarkepharmaceuticals.comUnapproved New Drugs/MisbrandedWarning LetterDrugs 01/25/2021“COVID-19 BLOOD SPOT COLLECTION PACKET” EnMed MicroAnalytics, Inc.645 Meeting St, Suite 2, Charleston, SC 29403-4279enmedmicroanalytics.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 01/25/2021“SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET"EnMed MicroAnalytics, Inc.645 Meeting St, Suite 2, Charleston, SC 29403-4279enmedmicroanalytics.comAdulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDevices 01/22/2021AloeCure VeraFlexAmerican Global Health Group, LLC11808 Northup Way, Suite W105, Bellevue, WA 98005aloecure.com; facebook.com/aloecureNew Drug/MisbrandedWarning LetterFoods 01/22/2021AloeCure Advanced Formula CapsuleAmerican Global Health Group, LLC11808 Northup Way, Suite W105, Bellevue, WA 98005aloecure.com; facebook.com/aloecureNew Drug/MisbrandedWarning LetterFoods 01/22/2021AloeCure Pure Aloe Vera ExtractAmerican Global Health Group, LLC11808 Northup Way, Suite W105, Bellevue, WA 98005aloecure.com; facebook.com/aloecureNew Drug/MisbrandedWarning LetterFoods 01/22/2021AloeCure Probiotic + EnzymeAmerican Global Health Group, LLC11808 Northup Way, Suite W105, Bellevue, WA 98005aloecure.com; facebook.com/aloecureNew Drug/MisbrandedWarning LetterFoods 01/19/2021Adam’s Secret Extra Strength 1500Various Distributorsn/aadamssecret.co; walmart.comUndeclared tadalafil and sildenafilPublic NotificationDrugsRecall01/19/2021Adam’s Secret Extra Strength 3000 PlatinumVarious Distributorsn/aadamssecret.coUndeclared tadalafil and sildenafilPublic NotificationDrugsRecall01/14/2021“Golden Milk Electuary-Mushroom Cocoa Blend”Sage Moon Apothecary LLC40 Main Street, Seal Harbor, ME 04675sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaineNew Drug/MisbrandedWarning LetterFoodsCloseout Letter01/14/2021“Golden Milk Electuary”Sage Moon Apothecary LLC40 Main Street, Seal Harbor, ME 04675sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaineNew Drug/MisbrandedWarning LetterFoodsCloseout Letter01/14/2021“Beyond Elderberry Syrup”Sage Moon Apothecary LLC40 Main Street, Seal Harbor, ME 04675sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaineNew Drug/MisbrandedWarning LetterFoodsCloseout Letter01/12/2021Allicin capsulesAllimax Us500 W Superior St Unit 2205, Chicago, IL 60654allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 01/12/2021Allicin creamsAllimax Us500 W Superior St Unit 2205, Chicago, IL 60654allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 01/12/2021Allicin gelsAllimax Us500 W Superior St Unit 2205, Chicago, IL 60654allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 01/12/2021Allicin spraysAllimax Us500 W Superior St Unit 2205, Chicago, IL 60654allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 01/12/2021Allicin liquid productsAllimax Us500 W Superior St Unit 2205, Chicago, IL 60654allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 01/12/2021“Corona Destroyer Tea”AusarHerbs201 S. D Street, Madera, CA 93639ausarherbs.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 01/06/2021Lion's Mane -All Natural SupplementEntia Biosciences, Inc13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140totalnutraceutical.comNew Drug/MisbrandedWarning LetterFoods 01/06/2021Antrodia Mushroom PowderEntia Biosciences, Inc13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140totalnutraceutical.comNew Drug/MisbrandedWarning LetterFoods 01/06/2021Maitake Mushroom PowderEntia Biosciences, Inc13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140totalnutraceutical.comNew Drug/MisbrandedWarning LetterFoods 01/06/2021Reishi Mushroom PowderEntia Biosciences, Inc13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140totalnutraceutical.comNew Drug/MisbrandedWarning LetterFoods 01/06/2021Cordyceps Mushroom PowderEntia Biosciences, Inc13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140totalnutraceutical.comNew Drug/MisbrandedWarning LetterFoods 01/06/2021Cordyceps - All Natural Mushroom Dietary SupplementEntia Biosciences, Inc13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140totalnutraceutical.comNew Drug/MisbrandedWarning LetterFoods 01/04/20214-Thieves Florida Tea ConcentrateCoco's Holistic Specialties & Apothecaryn/acocosholisticspecialties.org/; facebook.com/KaliLengua; twitter.com/CocoEtsyUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 01/04/20214-Thieves Florida Tea PowderCoco's Holistic Specialties & Apothecaryn/acocosholisticspecialties.org/; facebook.com/KaliLengua; twitter.com/CocoEtsyUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/28/2020Smarter CurcuminSmarter Nutrition, Inc.17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708smarternutrition.com; facebook.com/smarternutrition1New Drug/MisbrandedWarning LetterFoods 12/28/2020Smarter UbiquinolSmarter Nutrition, Inc.17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708smarternutrition.com; facebook.com/smarternutrition1New Drug/MisbrandedWarning LetterFoods 12/28/2020Smarter Vitamin D3Smarter Nutrition, Inc.17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708smarternutrition.com; facebook.com/smarternutrition1New Drug/MisbrandedWarning LetterFoods 12/22/2020Synotrex Speedwinds Nutrition, Inc.818 SW 3rd Avenue, Portland, OR 97204speedwindsnutrition.com; synotrex.com; amazon.comNew Drug/MisbrandedWarning LetterFoods 12/22/2020SephrenSpeedwinds Nutrition, Inc.818 SW 3rd Avenue, Portland, OR 97204speedwindsnutrition.com; synotrex.com; amazon.comNew Drug/MisbrandedWarning LetterFoods 12/22/2020RHINODOL CBD” nasal spray productsNew Leaf Pharmaceuticals, LLC77 South Main Street, Newton, CT 06470newleafpharma.com; facebook/CBDMedicalProducts/Finished Pharmaceuticals/Unapproved New Drug/MisbrandedWarning LetterDrugs 12/22/2020Various human and animal products, promoted to contain cannabidiol (CBD)NextL3vel Services Group, LLC dba This Stuff Is Good For You3400 W. Desert Inn Rd. Suite 2, Las Vegas, NV 89102thisstuffisgoodforyou.com; facebook.com/tsigfy; instagram.com/tsigfyFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs; Animal & Veterinary 12/22/2020“WBRx Metered-Dose Inhaler"Wellness BioSciences Rx9789 Katy Freeway #1801, Houston, TX 77024wbrxglobal.com; twitter.com/wellnessbiosrxFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 12/22/2020"WBRx Balance Softgels CBD”Wellness BioSciences Rx9789 Katy Freeway #1801, Houston, TX 77024wbrxglobal.com; twitter.com/wellnessbiosrxFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 12/22/2020“WBRx Pure Wellness CBD” (“WBRx Combo Pack”)Wellness BioSciences Rx9789 Katy Freeway #1801, Houston, TX 77024wbrxglobal.com; twitter.com/wellnessbiosrxFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 12/22/2020“WBRx Energy Oil Drops CBD”Wellness BioSciences Rx9789 Katy Freeway #1801, Houston, TX 77024wbrxglobal.com; twitter.com/wellnessbiosrxFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 12/22/2020“WBRx Relief Balm CBD” Wellness BioSciences Rx9789 Katy Freeway #1801, Houston, TX 77024wbrxglobal.com; twitter.com/wellnessbiosrxFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 12/22/2020“WBRx Sleep Oil Drops CBDWellness BioSciences Rx9789 Katy Freeway #1801, Houston, TX 77024wbrxglobal.com; twitter.com/wellnessbiosrxFinished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedWarning LetterDrugs 12/22/2020“Canna Bees Rescue Blend”Bee Delightfuln/abeedelightful.com; facebook.com/BeeDelightfulUSAUnapproved New Drugs/MisbrandedWarning LetterFoods 12/21/2020“C BETTER DAILY Adult Regular Formula”G & L Wellness, LLC2231 14th St S 114, Wisconsin Rapids, WI 54494glwellness.netFinished Pharmaceuticals/Unapproved New Drug/MisbrandedWarning LetterDrugs; Animal & Veterinary 12/21/2020“C BETTER DAILY Adult Maximum Formula” G & L Wellness, LLC2231 14th St S 114, Wisconsin Rapids, WI 54494glwellness.netFinished Pharmaceuticals/Unapproved New Drug/MisbrandedWarning LetterDrugs; Animal & Veterinary 12/21/2020“C BETTER DAILY Soothing Formula” G & L Wellness, LLC2231 14th St S 114, Wisconsin Rapids, WI 54494glwellness.netFinished Pharmaceuticals/Unapproved New Drug/MisbrandedWarning LetterDrugs; Animal & Veterinary 12/21/2020“Flu Immune Drops”Riverstone LLC51668 Blue River Dr, Blue River, OR 97413doctorschoice.orgUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/21/2020“L-Lysine”Riverstone LLC51668 Blue River Dr, Blue River, OR 97413doctorschoice.orgUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/21/2020“Lysine Extra”Riverstone LLC51668 Blue River Dr, Blue River, OR 97413doctorschoice.orgUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/21/2020“Monolaurin”Riverstone LLC51668 Blue River Dr, Blue River, OR 97413doctorschoice.orgUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/21/2020Organic Liposomal Vitamin CSparrow Health & Performance LLC2000 Southlake Park Suite 150, Hoover, AL 35244sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/21/2020Nanoemulsified D3K2 (also referred to as “Liquid Liposomal Vitamin D3 with K2” or “Liposomal Vitamin D3”Sparrow Health & Performance LLC2000 Southlake Park Suite 150, Hoover, AL 35244sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/21/2020Immune Support Package (which includes your Organic Liposomal Vitamin C, Nanoemulsified D3K2, and Virus Be Gone products, with Smart Silver as an optional add-on)Sparrow Health & Performance LLC2000 Southlake Park Suite 150, Hoover, AL 35244sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/18/2020“Glycostasis”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020“Glucosamine Curcumin”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020“Turmeric 50”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020“Turmeric Curcumin”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020“Cetyl Curcumin”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020“Ashwagandha”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020“Huruli”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020“Black Seed Oil”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020“Curcumin Turmerone”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020“Ashwagandha Honey”Reddy Naturals1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152reddynaturals.com; facebook.com/ReddyNaturalsNew Drug/MisbrandedWarning LetterDrugs 12/18/2020CloSYS Non-Irritating RINSE Mildly Flavored for SENSITIVE MouthsRowpar Pharmaceuticals16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260closys.com; facebook.com/ClosSYS; twitter.com/closysUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/18/2020CloSYS Oral SprayRowpar Pharmaceuticals16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260closys.com; facebook.com/ClosSYS; twitter.com/closysUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/18/2020CloSYS Non-Irritating RINSE UN-flavored for ULTRA SENSITIVE MouthsRowpar Pharmaceuticals16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260closys.com; facebook.com/ClosSYS; twitter.com/closysUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/17/2020Triple SupremeZen Plus 3500Various Distributors; Recall by Yolo Studio/Hyobin LLCn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Untitled Letter

12/17/2020Shogun-X BlackVarious Distributors; Recall by Ummzy LLC/Knabe Incn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Triple SupremeZen Extreme 3500Various Distributors; including seller Otwon/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Untitled Letter

12/17/2020Thumbs Up 7 White 11KVarious Distributors; Recall by Nuri Trading LLCn/aamazon.comUndeclared sildenafil, tadalafil and vardenafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Thumbs Up 7 Red 70KVarious Distributors; Recalls by Antoto-K and Ummzy LLC/Knabe Incn/aamazon.comUndeclared sildenafil, tadalafil and vardenafilPublic NotificationDrugs

News Release

Recall (Antoto-K)

Recall (Ummzy LLC/Knabe Inc)

Untitled Letter

12/17/2020Thumbs Up 7 Blue 69KVarious Distributors; Recall by Bit & Bet LLCn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Thumbs Up 7 Black 25KVarious Distributors; Recall by Nuri Trading LLCn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Rock Steady 72 HoursVarious Distributors; including seller Rock Steady 72 Hoursn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Untitled Letter

12/17/2020Red Spartan 3000Various Distributors; including seller Amazon.comn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Untitled Letter

12/17/2020Premium OrgaZen 7000Various Distributors; Recall by  NS NY Distributor Incn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Premier Platinum 5000 (PremierZEN Platinum 5000)Various Distributors; Recall by NANA Collection LLC/E-Factory NYn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020PremierZen Extreme 3000Various Distributors; Recalls by QMART and Yolo Studion/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Recall (QMART)

Recall (Yolo Studio)

Untitled Letter

12/17/2020PremierZen Black 5000Various Distributors; Recall by Namoo Enterprise LLC/All-R0undern/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Original White DragonVarious Distributors; including seller A&D Healthn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Untitled Letter

12/17/2020Krazy NightVarious Distributors; Recall by Ummzy LLC/Knabe Incn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Kopi Jantan Tradisional Natural Herbs CoffeeVarious Distributors; including seller smile_elephantn/aamazon.comUndeclared sildenafilPublic NotificationDrugs

News Release

Untitled Letter

12/17/2020Imperial Platinum 2000Various Distributors; Recall by QMARTn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Imperial Gold 2000Various Distributors; Recall by QMARTn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Imperial Extreme 2000Various Distributors; Recall by S&B Shopper LLCn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Hot RodVarious Distributors; including BZ USA LLC/BZ USA LLCn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Untitled Letter

12/17/2020Ginseng Power 5000Various Distributors; Recall by  NS NY Distributor Incn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Burro en Primavera 60000Various Distributors; Recall by QMARTn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/202069MODE Blue 69Various Distributors; Recall by Nuri Trading LLCn/aamazon.comUndeclared tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/20203 KO Gold XTVarious Distributors; including seller Vitality Maten/aamazon.comUndeclared vardenafilPublic NotificationDrugs

News Release

Untitled Letter

12/17/2020Shogun-X Platinum 7000Various Distributors; Recall by Nuri Trading LLCn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Triple SupremeZen Gold 3500Various Distributors; Recall by NANA Collection LLC/E-Factory NYn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

Untitled Letter

12/17/2020Burn 7Various Distributors; including seller befitaholic n/aebay.comUndeclared phenolphthaleinPublic NotificationDrugsNews Release12/17/2020Premier maxxzen Platinum 12000Various Distributors; including seller Miracle8989n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

12/17/2020Poseidon Platinum 10000Various Distributors; including seller co.american/aebay.comUndeclared vardenafilPublic NotificationDrugsNews Release12/17/2020Poseidon Platinum 3500Various Distributors; including seller Yamtun7n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

12/17/2020Mero MachoVarious Distributors; including seller setec24 n/aebay.comUndeclared tadalafilPublic NotificationDrugsNews Release12/17/2020Gold LionVarious Distributors; including seller unityhealth n/aebay.comUndeclared sildenafilPublic NotificationDrugsNews Release12/17/2020White PantherVarious Distributors; including seller qualmart1-9n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugsNews Release12/17/2020Triple Wicked PlatinumVarious Distributors; including seller pricemasters_usan/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugsNews Release12/17/2020The Super Panther 77kVarious Distributors; including seller qualmart1-9 n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugsNews Release12/17/2020Royal HoneyVarious Distributors; including seller ahmedjamilmuslim n/aebay.comUndeclared tadalafilPublic NotificationDrugsNews Release12/17/2020PremierZen Gold 7000Various Distributors; Recall by Miracle8989n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

12/17/2020PremierZen Platinum 8000Various Distributors; Recall by Miracle8989n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

12/17/2020Blue Panther Extreme 75kVarious Distributors; including seller qualmart1-9 n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugsNews Release12/17/2020Black Stallion 9000Various Distributors; including seller qualmart1-9 n/aebay.comUndeclared tadalafilPublic NotificationDrugsNews Release12/17/2020Lishou Slimming CoffeeVarious Distributors; including seller annday14n/aebay.comUndeclared sibutramine and desmethylsibutraminePublic NotificationDrugsNews Release12/17/2020Li Da Daidaihua PlusVarious Distributors; including seller micki_jayn/aebay.comUndeclared phenolphthaleinPublic NotificationDrugsNews Release12/17/2020Imperla Elita VitaccinoVarious Distributors; Recall by Dash Xclusiven/aebay.comUndeclared sibutramine and fluoxetinePublic NotificationDrugs

News Release

Recall

12/17/2020Fruta PlantaVarious Distributors; including seller aialoj0 n/aebay.comUndeclared sibutraminePublic NotificationDrugsNews Release12/17/2020Fruta BioVarious Distributors; including seller frutabio n/aebay.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugsNews Release12/17/2020Super SlimVarious Distributors; including seller emmcli0 n/aebay.comUndeclared sibutramine and desmethylsibutraminePublic NotificationDrugsNews Release12/15/2020“Oleander 4X”Phoenix Biotechnology, Inc.; Avila Herbals, LLC8626 Tesoro Dr., Suite 801, San Antonio, TX 78217 4025 Childress Rd., Christiansburg, VA 24073phoenixbiotechnology.com; myoleander.com; avilaherbals.com; twitter.com/PhoenixBioIncFinished Pharmaceuticals/Unapproved new drugWarning LetterDrugs 12/10/2020"Chest Tea” Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.com Finished Pharmaceuticals/Unapproved new drugWarning LetterFoods 12/10/2020“Ginger Oil”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.com Finished Pharmaceuticals/Unapproved new drugWarning LetterFoods 12/10/2020“Dandelion root Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.com Finished Pharmaceuticals/Unapproved new drugWarning LetterFoods 12/10/2020“Echinacea purpurea Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.com Finished Pharmaceuticals/Unapproved new drugWarning LetterFoods 12/10/2020“Antispasmodic Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.com Finished Pharmaceuticals/Unapproved new drugWarning LetterFoods 12/10/2020“Ginger Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.com Finished Pharmaceuticals/Unapproved new drugWarning LetterFoods 12/10/2020“Cayenne Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.com Finished Pharmaceuticals/Unapproved new drugWarning LetterFoods 12/10/2020VitaminsiThrive.healthn/aithrive.health; facebook.com/iTHRIVE.health/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/10/2020Quercetin productsiThrive.healthn/aithrive.health; facebook.com/iTHRIVE.health/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/10/2020Zinc productsiThrive.healthn/aithrive.health; facebook.com/iTHRIVE.health/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/10/2020Omega-3 productsiThrive.healthn/aithrive.health; facebook.com/iTHRIVE.health/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/10/2020Mineral productsIndigenous ProductsDallas, TX 75232facebook.com/Indigenous-Products-106070747498475/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/09/2020Healthy-Thin Energize”Bodyhealth.com, LLC707 Cleveland St. Clearwater, FL 33755-4107bodyhealth.com New Drug/MisbrandedWarning LetterFoods 12/09/2020“Body Detox (Oral Spray)”Bodyhealth.com, LLC707 Cleveland St. Clearwater, FL 33755-4107bodyhealth.com New Drug/MisbrandedWarning LetterFoods 12/09/2020“Omega 3 Health”Bodyhealth.com, LLC707 Cleveland St. Clearwater, FL 33755-4107bodyhealth.com New Drug/MisbrandedWarning LetterFoods 12/07/2020“Thymosin Alpha 1”Paradigm RE LLC1511 N. Convent 700-156 Bourbonnais, IL 60914paradigmpeptides.com/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/04/2020FortifyDesert Alchemist LLCTucson, AZetsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desertNew Drug/MisbrandedWarning LetterFoods 12/04/2020Lion's ManeDesert Alchemist LLCTucson, AZetsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desertNew Drug/MisbrandedWarning LetterFoods 12/04/2020The Great WorkDesert Alchemist LLCTucson, AZetsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desertNew Drug/MisbrandedWarning LetterFoods 12/04/2020Mind EaseDesert Alchemist LLCTucson, AZetsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desertNew Drug/MisbrandedWarning LetterFoods 12/04/2020Sweet BalanceDesert Alchemist LLCTucson, AZetsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desertNew Drug/MisbrandedWarning LetterFoods 12/04/2020Happy HeartDesert Alchemist LLCTucson, AZetsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desertNew Drug/MisbrandedWarning LetterFoods 12/04/2020Flair SnareDesert Alchemist LLCTucson, AZetsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desertNew Drug/MisbrandedWarning LetterFoods 12/04/2020Cordycepts sinensis double extractDesert Alchemist LLCTucson, AZetsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desertNew Drug/MisbrandedWarning LetterFoods 12/02/2020“Evening Primrose Oil”Smoky Mountain Naturals, LLC3605 Nebraska Avenue Nashville, TN 37209smnutrition.comNew Drug/MisbrandedWarning LetterFoods 12/02/2020“Beta Glucan"Smoky Mountain Naturals, LLC3605 Nebraska Avenue Nashville, TN 37209smnutrition.comNew Drug/MisbrandedWarning LetterFoods 12/02/2020C60 (Carbon 60), including “AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTION”Heavenly Natural Products100 Monroe St #406 Centerton, AR 72719heavenlynaturalproducts.com; facebook.com/heavenlyc60; twitter.com/hnpC60; pinterest.com/heavenlynaturalproductsc/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/02/2020Colloidal silver, including "Heavenly Silver"Heavenly Natural Products100 Monroe St #406 Centerton, AR 72719heavenlynaturalproducts.com; facebook.com/heavenlyc60; twitter.com/hnpC60; pinterest.com/heavenlynaturalproductsc/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/02/2020“VIRUS BIOSHIELD”Rat's Army4126 US HWY 93 S Kalispell, MT 59901rats.army/ Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 12/02/2020"Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and Probiotics”Health & Wellness Center International One, L.L.C. dba Hotze Vitamins20214 Braidwood, Ste. 215 Katy, TX 77450hotzehwc.com; hotzevitamins.com; facebook.com/Hotze-HWC/; facebook.com/MyHotzeVitamins/ twitter.com/hotzehealth.com; twitter.com/HotzeVitamins/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/02/2020“Dr. Hotze’s Kids Immune Pak”Health & Wellness Center International One, L.L.C. dba Hotze Vitamins20214 Braidwood, Ste. 215 Katy, TX 77450hotzehwc.com; hotzevitamins.com; facebook.com/Hotze-HWC/; facebook.com/MyHotzeVitamins/ twitter.com/hotzehealth.com; twitter.com/HotzeVitamins/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 12/02/2020“Dr. Hotze’s Teen Immune Pak”Health & Wellness Center International One, L.L.C. dba Hotze Vitamins20214 Braidwood, Ste. 215 Katy, TX 77450hotzehwc.com; hotzevitamins.com; facebook.com/Hotze-HWC/; facebook.com/MyHotzeVitamins/ twitter.com/hotzehealth.com; twitter.com/HotzeVitamins/Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoods 11/24/2020U.S.A. ViagraVarious Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Stree OverlordVarious Distributorsn/aExamination of imported goodsUndeclared sildenafil and ciprofloxacinPublic NotificationDrugs 11/24/2020Rhinozen 69 Platinum 75000Various Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Rhino 99 Extreme 90000Various Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Rhino 96 Platinum 77000Various Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Rhino 69 Platinum 25000Various Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Rhino 69 Power 500KVarious Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Rhino 8 Platinum 80000Various Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Body Shape Weight Loss SystemVarious Distributorsn/aExamination of imported goodsUndeclared sibutraminePublic NotificationDrugs 11/24/2020Bigger Longer More Time More Sperms (sic)Various Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Herb Viagra Male Sexual StimulantVarious Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Magnum XXL 50KVarious Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020Magnum XXL 9800Various Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/24/2020V8 Super EnergyVarious Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 11/18/2020Vigorous ManVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 11/18/2020LivtoneVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and fluoxetinePublic NotificationDrugs 09/01/2020Red-EThe Protein Shoppe, LLC101 E Exp. 83 Ste. A-1 Pharr, TX 78557The Protein Shoppe, LLCUndeclared sildenafilRecallDrugs 07/09/2020Tenadam HerbSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 07/09/2020Spiced TeaSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 07/09/2020Nigerian Moringa Leaf PowderSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 07/09/2020Jamaican TurmericSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 07/09/2020Bitter WoodSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 07/09/2020Devil HorsewhipSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 07/09/2020Mango LeafSundial Herbal Products3609 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approvalRecallDrugs 05/20/2020Sterile Cannabidiol (CBD) + Curcumin previously listed as Cannabidiol (CBD) + Curcumin ComplexBiota Biosciences, LLCSeattle, WAn/aUnapproved new drug; injectable products marketed without FDA approvalRecallDrugs 05/19/2020Dr. Rima RecommendsTM Nano Silver 10 PPMNatural Solutions Foundation58 Plotts Rd, Newton NJ 07860drrimatruthreports.com; opensourcetruth.com; truthaboutcoronavirus.com; nsfmarketplace.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterFoodsRecall05/11/2020“CORE”Fusion Health and Vitality LLC1360 Union Hill Road Suite 11B, Alpharetta, GA 30004pharmorigins.com; freecoreoffer.online; immune-shot.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugsRecall05/11/2020“IMMUNE SHOT”Fusion Health and Vitality LLC1360 Union Hill Road Suite 11B, Alpharetta, GA 30004pharmorigins.com; freecoreoffer.online; immune-shot.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugsRecall05/06/2020NAD+ Sublingual GelAlive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 05/06/2020NMN Sublingual GelAlive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)Warning LetterDrugs 04/22/2020Black Mamba Premium 18000Bandera Ice Housen/an/aUndeclared tadalafilPublic NotificationDrugs 03/16/2020Active MaleNatural Remedy StoreSan Antonio, TXNatural Remedy StoreUndeclared tadalafilRecallDrugs 02/24/2020Bow & ArrowMed Man Distributionn/aDistributed in the USA to Regal Labs and to their nationwide retailersUndeclared sildenafilRecallDrugs 02/05/2020XXX Platinum WOODIEVarious Distributorsn/aamazon.comUndeclared sildenafil and tadalafilPublic 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Corp.n/an/aUndeclared tadalafilPublic NotificationDrugs 12/13/2019PremierZEN Gold 7000Various Distributorsn/avoltcandyonline.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 12/09/2019Essential Oils, including Bergamot bergaptene free (Citrus bergamia), Listea Cubea, Cypress – Cupressus sempervirens, Cinnamon Leaf – Cinnamomum zeylanicum, Chamomile Roman – Anthemis nobilis, and Carrot Seed – Daucus carotaKelley Pure Essentials Oils404 W. 5th St. New Richmond, WI 54017kelleypureessentialoils.comNew DrugsOnline Advisory LetterFoods; Drugs 12/09/2019Herbal Detox PearlsCoochie CoutureP.O. Box 251 Selden, NY 11784coochiecouture.net/; instagram.com/coochiecouture_/; facebook.com/coochiecoutureeNew DrugsOnline Advisory LetterFoods; Drugs 12/09/2019Blood Sugar UltraBlood Sugar Ultra1140 S. Highbrook Street Suite 400 Akron, OH 44301healthtech24.net/diabetes-report; bloodsugarultra.comNew DrugsOnline Advisory LetterFoods; Drugs 12/09/2019SNAP Capsule FormulaSimply Natural Advanced Pharma (SNAP)n/aadhdsnap.com; facebook.com/SNAPtoday/; instagram.com/snap4health/; twitter.com/SNAP4ADHDNew DrugsOnline Advisory LetterFoods; Drugs 12/09/2019SNAP Liquid FormulaSimply Natural Advanced Pharma (SNAP)n/aadhdsnap.com; facebook.com/SNAPtoday/; instagram.com/snap4health/; twitter.com/SNAP4ADHDNew DrugsOnline Advisory LetterFoods; Drugs 12/04/2019Detox PlusVarious Distributorsn/aInternational Mail ShipmentsUndeclared tadalafil, paynantheine, and mitragyninePublic NotificationDrugs 11/14/2019Power KhanVarious Distributorsn/apowerkhanusa.comUndeclared desmethyl thiosildenafil, thioaildenafil, and aildenafilPublic NotificationDrugs 11/13/2019Man ErectVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 11/13/2019SHENGDAVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 09/06/2019Sheaya LenderVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and fluoxetinePublic NotificationDrugs 10/24/2019CholesLoHFL Solutions LLC13077 Bluff Creek Dr., Playa Vista, CA 90094choleslo.comUndeclared lovastatinPublic NotificationDrugsWarning Letter10/17/2019Skinny PillLose Fat Gain Life M&B4102 Orange Ave Ste 118 & 119, Long Beach, CA 90807losefatgainlifemb.comUndeclared 1,3-dimethylamylamine (DMAA)Public NotificationFoodsWarning Letter10/16/2019UP2Various Distributorsn/ahmherbs.comUndeclared sildenafilPublic NotificationDrugsRecall10/09/2019CHUVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafil and tadalafilPublic NotificationDrugs 09/26/2019Kim Whitening Pearl and Snowlotus CreamKim Co, LTD888/32 Bang Pree Industrial Estate , Samut Prakan, Samut Prakan Thailandn/aFound to contain 0.047 g/kg of mercuryAlertDrugsImport Alert 53-1809/26/2019Golden Pearl Beauty CreamGolden Pearl Cosmetics115/1 M , Quaid-e-Azam Industrial Estate , Kot Lakhpat, Lahore, Punjab Pakistann/aFoodsAlertDrugsImport Alert 53-1809/26/2019Chandni Whitening CreamSJ Enterprises222 CCA FF , DHA Phase 4 Sector CCA , Lahore, Punjab Pakistann/aFound to contain 8.79 g/kg of mercuryAlertDrugsImport Alert 53-1809/26/2019Goree Beauty CreamGoree Cosmeticsn/an/aFound to contain 17.2 g/kg of mercuryAlertDrugs 09/26/2019Sandal Whitening Beauty CreamMMC Cosmetics PakistanMain Bazar Rd , Karbirwala, Khanewal Pakistann/aFound to contain 13.1 g/kg of mercuryAlertDrugsImport Alert 53-1809/26/2019Monespa Express PeelingVarious Distributorsn/an/aFound to contain 5.03 g/kg of mercuryAlertDrugs 09/26/2019Face Fresh Beauty CreamShaheen Costmetics PVT LTDHouse #8, Block-A4 , P.G.E.C.M.S Punjab Society , Lahore, Punjab Pakistann/aFound to contain 18.5 g/kg of mercuryAlertDrugsImport Alert 53-1809/19/2019Green LumberGL HoldingsNewport Beach, Californiagetgreenlumber.com; greenlumber.comUndeclared tadalafilPublic NotificationDrugsRecall09/16/2019Macho Artificial Passion Fruit Flavored Vitamin C Liquid SupplementFitoterapia USA Inc.n/afitoterapiausa.comUndeclared tadalafilRecallDrugs 09/09/2019Anaconda Strong FormulaVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 09/09/2019La Pepa NegraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 09/09/2019Lung LeaderVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 09/06/2019LanugarVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and N-desmethylsibutraminePublic NotificationDrugs 09/06/2019JaDera PLUSVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine, N-desmethylsibutramine, and benproperinePublic NotificationDrugs 09/06/2019Love in SVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and N-desmethylsibutraminePublic NotificationDrugs 09/06/2019LOBOVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 09/06/2019Mero MachoVarious Distributorsn/afitoterapiausa.com; meromachodrink.comUndeclared tadalafilPublic NotificationDrugs 07/25/2019Chrysanthemum/Hibiscus Blend TeaMoyeam USA TEA, LLCn/apureamitea.com; getmoyeam.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Eagle TeaMoyeam USA TEA, LLCn/apureamitea.com; getmoyeam.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Qing Yun Moyeam TeaMoyeam USA TEA, LLCn/apureamitea.com; getmoyeam.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019NAD+/H2S EnergizerAlive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019NAD+ DefenderAlive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Pure NAD+ Sublingual tabletsAlive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Pure NAD+ Sublingual powderAlive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Liquid NAD+ Sublingual dropsAlive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Pure NAD+ Nasal Spray,Alive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019NMNs Sublingual tablets (30 ct and 240 ct)Alive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Pure NMN Sublingual powderAlive By Nature, Inc.2574 Whispering Pines Dr. Fleming Island, FL 32003alivebynature.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019PulverexxDoctor Eden LLC10030 NW 6th Terr. Miami, FL 33172doctoreden.com; facebook.com/dredenhealth/; twitter.com/DrMEden; pinterest.com/drmarioedenUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019GF20 Plus Oral SprayLeading Edge Health100 Fidelitone Way Elizabethton, TN 37643leadingedgehealth.com; genf20.com; gen20.comUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019GF20 Plus CapsulesLeading Edge Health100 Fidelitone Way Elizabethton, TN 37643biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Moses Kit (Moses Cream + Moses Oil)Bible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019IQ+ Joy, Sleep, AnxietyBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Essential Eye Oil for GlaucomaBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory 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CreamBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Clear NoseBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/25/2019Hair MaximizerBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFood; Drugs 07/25/2019Cancer Support (Big C Support)Bible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 07/22/2019Bido CBD for PetsCuraleaf, Inc.301 Edgewater Place Suite 405, Wakefield, MA 01880curaleafhemp.comUnapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2019CBD Disposable Vape PenCuraleaf, Inc.301 Edgewater Place Suite 405, Wakefield, MA 01880curaleafhemp.comUnapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 07/22/2019CBD 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Expanded Recall

Warning Letter

05/12/2015Slim Xtreme DiamondGlobe All Wellnessn/an/aUndeclared sibutraminePublic NotificationDrugs 05/12/2015Slim Xtreme PlatinumGlobe All Wellnessn/an/aUndeclared sibutraminePublic NotificationDrugs 05/04/2015Jianbu Huqian WanVarious Distributorsn/aInternational Mail ShipmentsUndeclared dexamethasone,  chlorpheniramine, and furosemidePublic NotificationDrugs 05/04/2015Saurean Fong Sep LinVarious Distributorsn/aInternational Mail ShipmentsUndeclared dexamethasone and cyproheptadinePublic NotificationDrugs 05/04/2015Asihuri Plus ForteVarious Distributorsn/aInternational Mail ShipmentsUndeclared dexamethasone and phenylbutazonePublic NotificationDrugs 05/04/2015Ginseng She Lian WanVarious Distributorsn/aInternational Mail ShipmentsUndeclared dexamethasone and chlorpheniraminePublic NotificationDrugs 04/30/2015King of RomanceVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 04/30/2015Viagra 007Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 04/30/2015Slim Forte Slimming CapsuleVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 04/30/2015Li Da Dai Dai Hua Slimming CapsuleVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 04/30/2015Black PantherVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 04/29/2015Fatloss Slimming BeautyVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 04/29/2015SuperiorVarious Distributorsn/adetoxtheweightaway.com; beeallnatural.netUndeclared sibutraminePublic NotificationDrugs 09/12/2014MezoVarious Distributorsn/an/aUndeclared benzylsibutraminePublic NotificationDrugs 04/21/2015Extreme Diamond 3000Various Distributorsn/alibidoshops.comUndeclared desmethyl carbodenafil and dapoxetinePublic NotificationDrugs 03/26/2015Green Algae CombinationCrane Beautyn/aInternational Mail ShipmentsUndeclared lorcaserinPublic NotificationDrugs 03/18/2015Xcel AdvancedVarious Distributorsn/abeenaturalnutrition.comUndeclared phenolphthaleinPublic NotificationDrugs 03/18/2015Ultimate BoostVarious Distributorsn/asportnutrition1.comUndeclared phenolphthaleinPublic NotificationDrugs 03/18/2015XcelVarious Distributorsn/azixiutangforyourfigure.comUndeclared fluoxetinePublic NotificationDrugs 03/18/2015Xcel AdvancedVarious Distributorsn/abeenaturalnutrition.comUndeclared phenolphthaleinPublic NotificationDrugs 03/10/2015UltraZxUltraZx, Labs, L.L.C.n/an/aUndeclared sibutramine and phenolphthaleinRecallDrugs 03/05/2015Black Mamba PremiumVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/05/2015Black Mamba HyperrushVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 03/05/2015African SupermanVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/05/2015L-Carnitine Sob Strengthening Version Slimming Miracle CapsuleVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 03/05/2015Black Ant KingVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/05/2015Bigger Longer More Time More SpermsVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/03/2015Herb ViagraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/03/2015Natural Max SlimmingVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafil, fluoxetine and sibutraminePublic NotificationDrugs 03/03/2015Diablos Eca Fire CapsVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafil, phenolphthalein, sibutramine and an analogue of sibutramine, deisobutylbenzylsibutraminePublic NotificationDrugs 03/03/2015Stiff NightsVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/03/2015Male Silkworm Moth Nourishing Oral LiquidVarious Distributorsn/aInternational Mail ShipmentsUndeclared vardenafilPublic NotificationDrugs 03/03/2015BaolongVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/03/2015Rhino Blitz Gold 3000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/03/2015Vim-25Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/02/2015MME MAXMANVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/02/2015FX3000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/02/2015Hard WangVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/02/2015Vigour 300Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/02/2015Santi ScalperVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/02/2015Plant VigraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/02/2015VigraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/02/2015Elimulating Weight & Toxin Keeping BeautyVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 03/02/2015Super Hard Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 03/02/2015Sex MenVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 02/28/2015Seven SlimVarious Distributorsn/aInternational Mail ShipmentsUndeclared phenolphthaleinPublic NotificationDrugs 02/28/2015Night ManVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 02/28/2015Libigrow XXX TremeVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 02/28/2015Nine SlimVarious Distributorsn/aInternational Mail ShipmentsUndeclared phenolphthaleinPublic NotificationDrugs 02/28/2015Oxy ELITE Pro Super ThermogenicVarious Distributorsn/aInternational Mail ShipmentsUndeclared fluoxetinePublic NotificationDrugs 02/27/201572HPVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 02/27/2015Tibet BabaoVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 02/27/2015Germany NiubianVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 02/27/2015Botanical Slimming (Red)Various Distributorsn/aInternational Mail ShipmentsUndeclared fluoxetinePublic NotificationDrugs 02/25/2015Lean Body ExtremeVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine, desmethyl sibutramine, phenolphthalein, and sildenafilPublic NotificationDrugs 02/09/2015BtRim MaxDetox Transforms Health and NutritionGarner, NCn/aUndeclared phenolphthaleinRecallDrugs 02/09/2015AMPD Gold Bee PollenDetox Transforms Health and NutritionGarner, NCn/aUndeclared sildenafil RecallDrugs 02/09/2015iNDiGODetox Transforms Health and NutritionGarner, NCn/aUndeclared phenolphthaleinRecallDrugs 02/09/2015EDGE Amplified Weight ReleaseDetox Transforms Health and NutritionGarner, NCn/aUndeclared phenolphthalein and fluoxetineRecallDrugs 02/09/2015iNSANE Bee PollenDetox Transforms Health and NutritionGarner, NCn/aUndeclared phenolphthalein and fluoxetineRecallDrugs 02/03/2015Yanhee SlimVarious Distributorsn/an/aUndeclared lorcaserinPublic NotificationDrugs 01/21/2015Happy PassengersVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 12/23/2014Zhansheng Weige Chaoyue XilishiVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 12/23/2014Triple PowerZenVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 12/23/2014Samurai-XVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 12/23/2014Slim-KBethel Nutritional Consulting, Inc.New York, NYbethel30.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugsRecall12/19/2014B-LipoBethel Nutritional Consulting, Inc.New York, NYbethel30.comUndeclared lorcaserinRecallDrugs 11/25/2014Slim VieVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 11/25/2014Bee ThinVarious Distributorsn/abeethinzxt.comUndeclared sibutraminePublic NotificationDrugs 11/24/2014Super Extreme AcceleratorVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 11/24/2014Bee SlimVarious Distributorsn/aInternational Mail ShipmentsUndeclared Public NotificationDrugs 11/24/2014Black StormVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 11/20/2014Feng Shi Ling by Hong Kong Chi Chun Tang Herbal FactoryVarious Distributorsn/an/aUndeclared diclofenac and indomethacinPublic NotificationDrugs 11/19/2014Forever Beautiful Bee PollenREFA Enterprises, LLCn/an/aUndeclared sibutramine and/or phenolphthaleinRecallDrugs 11/19/2014Forever Beautiful InfinityREFA Enterprises, LLCn/an/aUndeclared sibutramine and/or phenolphthaleinRecallDrugs 11/14/2014MayhemChaotic-LabzAtkins, ARn/aUndeclared dexamethasoneRecallDrugs 11/04/2014V26 Slimming CoffeeVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/30/2014Ginseng Kianpi PilKweilin Drug Manufactoryn/aginsengkianpipil.comUndeclared dexamethasonePublic NotificationDrugs 10/10/2014Sit and Slim IIVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 09/26/2014Mojo RisenNova Products, Inc.5 Mount Pleasant Road, Aston, PA 19014n/aUndeclared sildenafil Warning LetterDrugs 09/26/2014XZone 1200Nova Products, Inc.5 Mount Pleasant Road, Aston, PA 19014n/aUndeclared sildenafil and tadalafilWarning LetterDrugs 09/26/2014XZone GoldNova Products, Inc.5 Mount Pleasant Road, Aston, PA 19014n/aUndeclared sildenafil and tadalafilWarning LetterDrugs 09/26/2014XZen PlatinumNova Products, Inc.5 Mount Pleasant Road, Aston, PA 19014n/aUndeclared sildenafil and tadalafilWarning LetterDrugs 09/26/2014Black AntNova Products, Inc.5 Mount Pleasant Road, Aston, PA 19014n/aUndeclared sildenafil Warning LetterDrugs 09/26/2014African Black AntNova Products, Inc.5 Mount Pleasant Road, Aston, PA 19014n/aUndeclared sildenafil Warning LetterDrugs 09/12/2014LX1Various Distributorsn/adrskinsecret.comUndeclared DMAAPublic NotificationFoods 09/12/2014Best Line Suplemento Alimenticio CapsulesVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 08/11/2014ArizeVarious Distributorsn/acalcompnutrition.comUndeclared sulfoaildenafilPublic NotificationDrugs 08/11/2014Herbal Vigor Quick FixVarious Distributorsn/acalcompnutrition.comUndeclared tadalafilPublic NotificationDrugs 07/22/2014O.M.GVarious Distributorsn/asears.comUndeclared sildenafilPublic NotificationDrugs 07/08/2014Mix Fruit SlimmingVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 07/08/2014Lipo 8 Burn SlimVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 07/08/201424 InceVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 07/08/2014Sliming Diet By Pretty WhiteVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 07/08/2014Lingzhi Cleansed Slim TeaVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 07/08/2014Trim-Fast Slimming SoftgelVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 06/17/2014Miraculous Evil RootVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 06/17/2014Toxin Discharged TeaVarious Distributorsn/an/aUndeclared fluoxetinePublic NotificationDrugs 06/17/2014Sport BurnerVarious Distributorsn/an/aUndeclared fluoxetinePublic NotificationDrugs 06/17/2014Gold VigraVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 06/17/2014Sliming DietVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 06/10/2014La Jiao Shou ShenVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 06/05/2014B-PerfectVarious Distributorsn/aicanb-perfect.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 06/02/2014EyefulVarious Distributorsn/an/aUndeclared hydroxythiohomosildenafilPublic NotificationDrugs 06/02/20143 Hard KnightsVarious Distributorsn/an/aUndeclared sildenafil and thiosildenafiPublic NotificationDrugs 06/02/2014Liu Bian LiVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 06/02/2014Full Throttle On DemandVarious Distributorsn/aoverstock.comUndeclared propoxyphenyl sildenafilPublic NotificationDrugs 06/02/2014Dick's Hard UpVarious Distributorsn/an/aUndeclared tadalafilPublic NotificationDrugs 06/02/2014GoldReallasVarious Distributorsn/an/aUndeclared sildenafil and thiosildenafiPublic NotificationDrugs 05/16/2014MV 5 DaysVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 05/16/2014Asset BoldVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 05/12/2014Asset Bee PollenVarious Distributorsn/aassetcapsules4u.comUndeclared sibutraminePublic NotificationDrugs 05/05/2014Natural Body SolutionVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 05/05/2014Slim Trim UVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 04/21/2014Super ArthgoldNano Well-being Health Inc.La Mirada, CAn/aUndeclared chlorzoxazone, diclofenac and indomethacinRecallDrugs 04/16/2014S.W.A.GVarious Distributorsn/asexwithagrudge.comUndeclared sildenafilPublic NotificationDrugs 04/10/2014Lite Fit USAVarious Distributorsn/aherbsultimate.comUndeclared sibutraminePublic NotificationDrugs 04/10/2014InfinityVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 04/09/2014ThinogenicsNature’s Universen/ashopnaturesuniverse.com; easy2loseweight.comUndeclared sibutramineRecallDrugs 04/02/2014New YouVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 03/26/2014Bella Vi Insane Bee Pollen CapsulesPure Edge Nutrition, LLCToms River, NJn/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 03/26/2014Bella Vi BTrim Ultimate BoostPure Edge Nutrition, LLCToms River, NJn/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 03/26/2014Bella Vi BTrim MaxPure Edge Nutrition, LLCToms River, NJn/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 03/26/2014Bella Vi Extreme AcceleratorPure Edge Nutrition, LLCToms River, NJn/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 03/26/2014Bella Vi Insane Amp’dPure Edge Nutrition, LLCToms River, NJn/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 03/26/2014Bella Vi Amp’d UpPure Edge Nutrition, LLCToms River, NJn/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 03/26/2014Super Fat Burner New Life Nutritional Centern/an/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 03/26/2014Maxi GoldNew Life Nutritional Centern/an/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 03/26/2014Esmeralda New Life Nutritional Centern/an/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 03/19/2014Vitaccino CoffeeVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 03/07/2014Weekend WarriorVarious Distributorsn/aonlinecoralcalcium.comUndeclared thiosildenafilPublic NotificationDrugs 02/13/2014Arth-Q, “알쓰큐” or “알쓰Q"Various Distributorsn/akaymall.comUndeclared ibuprofenPublic NotificationDrugs 02/04/2014Magic SlimMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramine, N-desmethylsibutramine and benzylsibutramineRecallDrugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014Fruta BioMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramine and phenolphthaleinRecallDrugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014SlimEasyMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramine and N-desmethylsibutramineRecallDrugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014Super Fat Burning BombMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared N-desthylsibutraminea nd phenolphthaleinRecallDrugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014Slim XtremeMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramine, N-desmethylsibutramine and benzylsibutramineRecallDrugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014Meizi EvolutionMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramine, N-desmethylsibutramine and benzylsibutramineRecallDrugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014Meizitang Strong Version Botanical SlimmingMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramine, N-desmethylsibutramine and benzylsibutramineRecallDrugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014Jianfeijindan Activity GirlMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared N-di-desmethylsibutramineRecallDrugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pillMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared phenolphthaleinRecallDrugs

Warning Letter

Additional Recall

Consent Decree

02/04/2014Reduce Weight Fruta PlantaMyNicNaxs, Inc.1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared phenolphthaleinRecallDrugs

Warning Letter

Additional Recall

Consent Decree

01/28/2014Bali MojoVarious Distributorsn/an/aUndeclared tadalafilPublic NotificationDrugs 01/28/2014Hot DetoxVarious Distributorsn/ahotdetoxllc.comUndeclared sibutraminePublic NotificationDrugs 01/28/2014Citrus Fit GoldCitrus Fit Weight Loss and Detox Products, LLCn/acitrusfit.comUndeclared sibutraminePublic NotificationDrugsWarning Letter01/28/2014JINQIANGBUDOR Red DragonVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 01/28/2014Tiger KingVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 01/28/2014SexRxVarious Distributorsn/aalternative-health-supplements.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 01/28/2014Tonic Life BPVarious Distributorsn/atonic-life-products.comUndeclared phenolphthaleinPublic NotificationDrugs 01/21/2014Dream Body Slimming CapsuleSlim Beauty USA503 E. 23rd St. Kearney, NE 68847slimbeautyusa.comUndeclared sibutraminePublic NotificationDrugsWarning Letter01/21/2014Magic SlimSlim Beauty USA503 E. 23rd St. Kearney, NE 68847slimbeautyusa.comUndeclared sibutraminePublic NotificationDrugsWarning Letter01/15/2014Pro ArthMaxVarious Distributorsn/an/aUndeclared diclofenac, ibuprofen, naproxen, indomethacin, nefopam, and chlorzoxazonePublic NotificationDrugs 01/09/2014Magic for MenMidwest WholesaleNixa, MOn/aUndeclared sildenafil and/or tadalafilRecallDrugs 01/09/2014Boost UltraMidwest WholesaleNixa, MOn/aUndeclared sildenafil and/or tadalafilRecallDrugs 01/09/2014XZone GoldMidwest WholesaleNixa, MOn/aUndeclared sildenafil and/or tadalafilRecallDrugs 01/09/2014Sexy MonkeyMidwest WholesaleNixa, MOn/aUndeclared sildenafil and/or tadalafilRecallDrugs 01/09/2014Triple MiracleZen PlatinumMidwest WholesaleNixa, MOn/aUndeclared sildenafil and/or tadalafilRecallDrugs 01/09/2014"New" ExtenzeMidwest WholesaleNixa, MOn/aUndeclared sildenafil and/or tadalafilRecallDrugs 01/09/2014New XZen PlatinumMidwest WholesaleNixa, MOn/aUndeclared sildenafil and/or tadalafilRecallDrugs 12/23/2013Burn 7Deseo Rebajar Inc.n/adeseorebajar.comUndeclared phenolphthaleinPublic NotificationDrugsRecall12/23/2013Mass DestructionBlunt Force Nutritionn/an/aLabeled to contain at least one synthetic anabolic steroidPress ReleaseDrugs 12/19/2013SlimEasy Herbs CapsuleVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 12/19/2013CONTROL All Natural Sexual EnhancementVarious Distributorsn/an/aUndeclared sulfoaildenafil and dimethylsildenafilPublic NotificationDrugs 12/19/2013Asset Extreme PlusVarious Distributorsn/aallnaturalbeelievers.comUndeclared sibutraminePublic NotificationDrugs 12/19/2013Best WhipsVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 12/19/2013Asset ExtremeVarious Distributorsn/aassetcapsules4u.comUndeclared sibutraminePublic NotificationDrugs 12/19/20137 Days Herbal SlimVarious Distributorsn/asuncoastspaequipment.comUndeclared sibutramine Public NotificationDrugs 12/19/2013Dr. Ming's Chinese CapsuleVarious Distributorsn/aslimbeautyusa.comUndeclared sibutramine Public NotificationDrugsWarning Letter12/19/2013Sliming Diet Berry PlusVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 12/19/2013Meizitang CitrusVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 11/29/2013HydravaxIQ FormulationsSunrise, FLn/aUndeclared diureticRecallDrugs 11/21/2013Alpha MaleVarious Distributorsn/an/aUndeclared aminotadalafil, sulfosildenafil, sulfoaildenafil, hydroxythiohomosildenafil, dimethylsildenafil, and sildenafilPublic NotificationDrugs 11/21/2013SlimExtra Herbal CapsulesVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 11/21/2013Body Beauty 5 Days Slimming CoffeeVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 11/21/2013Diet MasterVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 11/21/2013Super SlimVarious Distributorsn/abonanza.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 11/20/2013Slim MaxVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 11/19/2013P-BoostTendex Los Angeles, CAn/aUndeclared tadalafil RecallDrugs 11/19/2013NatuRECTTendex Los Angeles, CAn/aUndeclared tadalafil RecallDrugs 11/18/2013RezzRXFossil Fuel Products, LLCn/an/aUndeclared hydroxylthiohomosildenafil and aminotadalafilRecallDrugs 11/16/2013Rhino 5 PlusJobbers WholesaleParamount, CAn/aUndeclared desmethylcarbondenafil and dapoxetineRecallDrugs 11/16/2013MaxtremezenJobbers WholesaleParamount, CAn/aUndeclared desmethylcarbondenafil and dapoxetineRecallDrugs 11/16/2013ExtenzoneVarious DistributorsParamount, CAn/aUndeclared desmethylcarbondenafil and dapoxetineRecallDrugs 11/14/2013Adipotrim XTDeseo Rebajar Inc.n/adeseorebajar.comUndeclared fluoxetineRecallDrugs 11/08/2013Vitalikor Fast ActingVarious Distributorsn/avitalityreseasrchlabs.com; vitalikor.com; gnc.comUndeclared tadalafil and vardenafilPublic NotificationDrugs 11/07/2013Jimpness Beauty Fat Loss CapsulesVarious Distributorsn/ajimpness.netUndeclared ramine, phenolphthalein, and sildenafilPublic NotificationDrugs 11/05/2013Goodliness Fat-Reducing CapsulesVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 10/10/2013Be InspiredVarious Distributorsn/abeinspirednaturally.comUndeclared sibutraminePublic NotificationDrugs 10/10/2013Dr. Mao Slimming CapsulesVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/10/2013Perfect Body Solutions Various Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/10/2013Bella Vi Insane Amp’d Various Distributorsn/apureedgenutrition.com; newedgenutrition.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 10/10/2013Bella Vi Amp’d UpVarious Distributorsn/apureedgenutrition.com; newedgenutrition.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 10/07/2013LidiyB@B Trade, IncFLlidiy.comUndeclared sibutramineRecallDrugs 10/07/2013Slim FortuneB@B Trade, IncFLslimfortune.comUndeclared sibutramineRecallDrugs 10/07/2013Slim ExpertB@B Trade, IncFLslimexpert.comUndeclared sibutramineRecallDrugs 09/24/2013Virilis ProHaute Health, LLCWilliamstown, NJvirilispro.comUndeclared sildenafilRecallDrugs 09/24/2013PHUK Haute Health, LLCWilliamstown, NJvirilispro.comUndeclared sildenafilRecallDrugs 09/24/2013Prolifta Haute Health, LLCWilliamstown, NJvirilispro.comUndeclared sildenafilRecallDrugs 09/24/2013XZen XpressVarious Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 09/24/2013XZen 1200Various Distributorsn/an/aUndeclared tadalafilPublic NotificationDrugs 09/24/2013XZone PremiumVarious Distributorsn/an/aUndeclared sildenafil, tadalafil, and dapoxetinePublic NotificationDrugs 09/24/2013Xzen GoldVarious Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 09/24/2013Wood-EVarious Distributorsn/anetnutri.comUndeclared sildenafilPublic NotificationDrugs 09/24/2013Instant Slim, 收腹提臀果香型减肥胶囊, Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang, or Сокращать живот и повышать 3адVarious Distributorsn/ainstantslim.orgUndeclared sibutraminePublic NotificationDrugs 08/27/2013Pro Power MaxHardmenstore.comFort Lauderdale, FLn/aUndeclared sildenafilRecallDrugs 08/27/2013Evil RootHardmenstore.comFort Lauderdale, FLn/aUndeclared sildenafilRecallDrugs 08/27/201372HPHardmenstore.comFort Lauderdale, FLn/aUndeclared sildenafilRecallDrugs 08/22/2013OrtigaVarious Distributorsn/aebay.comUndeclared diclofenacPublic NotificationDrugs 08/07/2013TranquilityHealth and Beyond, LLCBoca Raton, FLn/aUndeclared doxepin and chlorpormazine RecallDrugs 08/05/2013Quick ThinBethel Nutritional Consulting, Inc.New York, NYbethel30.comUndeclared sibutramine and phenolphthaleinRecallDrugs 08/05/2013Bethel AdvanceBethel Nutritional Consulting, Inc.New York, NYbethel30.comUndeclared sibutramine and phenolphthaleinRecallDrugs 07/19/2013Esbelin siloutte teHerbal Give Care LLCGrand Prairie, TXn/aUndeclared Ssbutramine, N-desmethylsibutramine, and N-di-desmethylsibutramineRecallDrugs 07/19/2013Esbelin siloutte Herbal Blend with L-CarnitineHerbal Give Care LLCGrand Prairie, TXn/aUndeclared Ssbutramine, N-desmethylsibutramine, and N-di-desmethylsibutramineRecallDrugs 07/18/2013Volcano Male Enhancement LiquidVolcano CompanyLong Beach, CAn/aUndeclared desmethyl carbodenafil, dimethylsildenafil, and dapoxetineRecallDrugs 07/18/2013Volcano Male Enhancement CapsulesVolcano CompanyLong Beach, CAn/aUndeclared desmethyl carbodenafil and dapoxetineRecallDrugs 06/28/2013ClalisVarious Distributorsn/ahardmenstore.comUndeclared sildenafilPublic NotificationDrugs 06/28/2013MaxTreme ZenVarious Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 06/28/2013Exten 1300Various Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 06/28/2013MVP MegaVarious Distributorsn/an/aUndeclared tadalafilPublic NotificationDrugs 06/27/2013Meizi EvolutionVarious Distributorsn/aebay.comUndeclared sibutraminePublic NotificationDrugs 06/27/2013Strawberry BalanceVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 06/27/2013Silver SwordVarious Distributorsn/ahardmenstore.comUndeclared sildenafilPublic NotificationDrugs 06/18/2013Fat ZeroVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 06/18/2013Fruit & Plant SlimmingVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 06/18/2013Royal Dragon Herbal Tonic BallsVarious Distributorsn/an/aUndeclared vardenafilPublic NotificationDrugs 06/18/2013Extreme Body SlimVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 06/18/2013Paiyouji PlusVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 06/10/2013Get It UpVarious Distributorsn/aebay.comUndeclared sildenafilPublic NotificationDrugs 06/10/2013Super CheetahVarious Distributorsn/abonanza.comUndeclared sildenafilPublic NotificationDrugs 06/10/2013XIYOUJI QINGZHI CAPSULEVarious Distributorsn/ajadera.netUndeclared sibutraminePublic NotificationDrugs 06/10/2013X Zen PlatinumVarious Distributorsn/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 06/10/2013Nights to RememberVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 06/10/2013Cave DiverVarious Distributorsn/abonanza.comUndeclared sildenafilPublic NotificationDrugs 06/10/2013ReloadVarious Distributorsn/areloadpill.comUndeclared sildenafilPublic NotificationDrugs 06/10/2013Bethel 30Bethel Nutritional Consulting, Inc.New York, NYbethel30.comUndeclared sibutraminePublic NotificationDrugs

Recall

Expanded Recall

06/10/2013Mojo RisenVarious Distributorsn/aebay.comUndeclared noracetildenafilPublic NotificationDrugs 05/07/2013SexVoltz BeaMonstar ProductsQueen Creek, AZn/aUndeclared tadalafilRecallDrugsExpanded Recall05/07/2013Velextra BeaMonstar ProductsQueen Creek, AZn/aUndeclared tadalafilRecallDrugs 05/07/2013Amerect BeaMonstar ProductsQueen Creek, AZn/aUndeclared tadalafilRecallDrugs 05/07/2013Lightning RodChang Kwungn/an/aUndeclared analogue of sildenafilRecallDrugs 05/07/2013Bullet ProofVarious Distributorsn/an/aUndeclared tadalafilPublic NotificationDrugs 05/01/2013VicerexAmerican Lifestyle640 Kreag Road, Pittsford, NY 14534n/aUndeclared tadalafil RecallDrugs 05/01/2013Black AntAmerican Lifestyle640 Kreag Road, Pittsford, NY 14534n/aUndeclared sildenafilRecallDrugs 04/25/2013Zoom-Zooma-ZoomAmrutam Life Care Pvt. Ltd.Indiaamrutamlifecare.comUndeclared sildenafilPublic NotificationDrugsWarning Letter04/25/2013Sex PlusVarious Distributorsn/an/aUndeclared sildenafil, tadalafil, sulfosildenafil and dimethylacetildenafilPublic NotificationDrugs 04/11/2013Affirm XLAffirm XL, Incn/an/aUndeclared analogue of sildenafilRecallDrugs 04/04/2013MAXILOSS Weight Advanced BlueVarious Distributorsn/aextremevitaminworld.com; dreamlifeweightloss.comUndeclared sibutraminePublic NotificationDrugs 04/03/2013Love RiderVarious Distributorsn/an/aUndeclared tadalafilPublic NotificationDrugs 04/03/2013Ninja MojoVarious Distributorsn/an/aUndeclared tadalafilPublic NotificationDrugs 03/21/2013Stiff DaysVarious Distributorsn/astiffdays.comUndeclared sildenafilPublic NotificationDrugs 03/21/2013Libido Sexual EnhancerVarious Distributorsn/avegasredpleasure.comUndeclared hydroxythiohomosildenafil, hydroxyhomosildenafil, sildenafil, and tadalafilPublic NotificationDrugs 03/12/2013Night BulletGreen Planet, Inc.Riverside, CAn/aUndeclared sulfohydroxyhomosildenafil and aminotadalafilRecallDrugs 01/24/2013Super PowerD&S Herbals, LLC, d/b/a Freedom TradingWoodbridge, NJn/aUndeclared sildenafilRecallDrugs 01/08/2013MAXILOSS Weight AdvancedVarious Distributorsn/adreamlifeweightloss.comUndeclared sibutraminePublic NotificationDrugs 12/19/2012WOWRiger Naturals S.A.n/agonepainfree.com; browerent.com; refumofanusa.comUndeclared dexamethasone, diclofenac sodium and methocrabamolPublic NotificationDrugsConsumer Update12/19/2012Slimdia RevolutionP&J Tradingn/apinkfatty.comUndeclared sibutramineRecallDrugsPublic Notification12/17/2012Libigrow XXXPerformance Plus Marketing, Inc.CAn/aUndeclared sulfoaildenafil and thioaidenafilRecallDrugs 12/17/2012CasanovaPerformance Plus Marketing, IncCAn/aUndeclared sulfoaildenafil and thioaidenafilRecallDrugs 12/17/2012Mojo NightsPerformance Plus Marketing, IncCAn/aUndeclared sulfoaildenafil and thioaidenafilRecallDrugs 12/17/2012Mojo Nights SupremePerformance Plus Marketing, IncCAn/aUndeclared sulfoaildenafil and thioaidenafilRecallDrugs 12/17/2012Blue Diamond PlatinumPerformance Plus Marketing, IncCAn/aUndeclared sulfoaildenafil and thioaidenafilRecallDrugs 12/17/2012LibigrowPerformance Plus Marketing, IncCAn/aUndeclared sulfoaildenafil and thioaidenafilRecallDrugs 12/17/2012Blue DiamondPerformance Plus Marketing, IncCAn/aUndeclared sulfoaildenafil and thioaidenafilRecallDrugs 11/08/2012Best Share Green Coffee: Brazilian Slimming CoffeeVarious Distributorsn/ahouseofmonet.comUndeclared sibutraminePublic NotificationDrugs 11/08/2012Beautiful Slim BodyVarious Distributorsn/ahouseofmonet.comUndeclared sibutraminePublic NotificationDrugs 11/08/2012Japan Hokkaido Slimming Weight Loss PillsVarious Distributorsn/aebay.comUndeclared sibutraminePublic NotificationDrugs 10/24/2012Classic Zi Xiu Tang Bee PollenZi Xiu Tang Success, LLCTrexlertown, PAn/aUndeclared sibutramineRecallDrugs 10/24/2012Ultimate Formula CapsulesZi Xiu Tang Success, LLCTrexlertown, PAn/aUndeclared sibutramineRecallDrugs 10/04/2012Tianji True SlimVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 09/12/2012ACTRA-Sx 500Body Basics Inc.n/an/aUndeclared sildenafilRecallDrugs 08/23/2012Mojo NightsEvol Nutrition Associates, Inc./Red DawnKennesaw, GAn/aUndeclared tadalafil and sildenafilRecallDrugs 08/21/2012Reumofan Plus PremiumRiger Naturals S.A.n/an/aUndeclared diclofenac sodium and methocarbamolNews ReleaseDrugs

Consumer Update

Recall

08/03/2012Best SlimCTV Best Group Inc.Duluth, GAbestslim.netUndeclared sibutramineRecallDrugs 07/20/2012X-Rock 3 Day Pill for MenCRM LaboratoriesDistributed by: XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312; or MATE Enterprises, 1020 N. Venetian Drive, Miami, Florida 33139xrockhim.comUndeclared sildenafil and hydroxythiohomosildenafilRecallDrugs 07/20/2012Z-RockCRM LaboratoriesDistributed By: XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312zrockusa.comUndeclared sildenafil and hydroxythiohomosildenafilRecallDrugs 06/01/2012Reumofan PlusRiger Naturals S.A.n/an/aUndeclared dexamethasone, diclofenac sodium and methocarbamolNews ReleaseDrugsConsumer Update05/25/2012Mojo NightsVarious Distirbutorsn/an/aUndeclared sulfoaildenafil, sulfosildenafil, and hydroxythiohomosildenafilPublic NotificationDrugs 05/25/2012Kaboom Action StripsVarious Distributorsn/akaboomformen.comUndeclared sulfoaildenafilPublic NotificationDrugs 05/22/2012EreXiteVarious Distributorsn/aamazon.comUndeclared tadalafilPublic NotificationDrugs 05/18/2012LibidronWest Coast Nutritionals, Ltd.n/alibidron.com; amazon.comUndeclared tadalafilRecallDrugs 05/18/2012FirminiteWest Coast Nutritionals, Ltd.n/afirminite.com; amazon.comUndeclared tadalafilRecallDrugs 05/18/2012Extra Strength Instant Hot RodWest Coast Nutritionals, Ltd.n/ainstanthotrodextrastrength.com; amazon.comUndeclared tadalafilRecallDrugs 05/16/2012VMaxx RxVarious Distributorsn/avmaxxrx.comUndeclared sulfoaidenafilPublic NotificationDrugs 05/16/2012Boost — Ultra Sexual Enhancement FormulaVarious Distributorsn/aboostultra.bizUndeclared Public NotificationDrugs 04/20/2012ZenMaxxEnhance NutraceuticalMalaysiazenmaxx.comUndeclared  aminotadalafilPublic NotificationDrugsWarning Letter04/20/2012Instant Hard RodEnhance NutraceuticalMalaysiainstanthardrod.comUndeclared aminotadalafilPublic NotificationDrugsWarning Letter04/20/2012RigiRx PlusEnhance NutraceuticalMalaysiarigirxplus.comUndeclared aminotadalafilPublic NotificationDrugsWarning Letter04/05/2012African Black AntVarious Distributorsn/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 04/05/2012France T253Various Distributorsn/aebay.comUndeclared sildenafilPublic NotificationDrugs 04/03/2012Japan Rapid Weight Loss Diet Pills YellowXiushentangn/aebay.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 04/03/2012Japan Rapid Weight Loss Diet Pills GreenXiushentangn/aebay.comUndeclared phenolphthaleinPublic NotificationDrugs 02/22/2012Mince BelleHealthy People Co.13105 Ramona Blvd Ste F, Irwindale, CA, 91706n/aUndeclared sibutramineRecallDrugs 02/22/2012EverlaxHealthy People Co.13105 Ramona Blvd Ste F, Irwindale, CA, 91706n/aUndeclared sibutramineRecallDrugs 02/22/2012Ever SlimHealthy People Co.13105 Ramona Blvd Ste F, Irwindale, CA, 91706n/aUndeclared sibutramineRecallDrugs 02/22/2012Ever Slim Shake MixHealthy People Co.13105 Ramona Blvd Ste F, Irwindale, CA, 91706n/aUndeclared sibutramineRecallDrugs 02/22/2012Acai-Man Mangosteen Herbal DrinkHealthy People Co.13105 Ramona Blvd Ste F, Irwindale, CA, 91706n/aUndeclared tadalafilRecallDrugs 02/22/2012Perfect MenHealthy People Co.13105 Ramona Blvd Ste F, Irwindale, CA, 91706n/aUndeclared tadalafilRecallDrugs 02/18/2012Japan Weight Loss BlueVarious Distributorsn/avitaminbestbuy.comUndeclared sibutramine and ephedrine alkaloidsPublic NotificationDrugs 02/18/2012Man KingVarious Distributorsn/avitaminbestbuy.comUndeclared sildenafilPublic NotificationDrugs 02/18/2012Hard Ten DaysVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 02/10/2012RegenArouseRegeneca, Inc.n/an/aUndeclared tadalafilRecallDrugs 11/10/2011Virility MaxKeime Inc dba Barry's Vitaminsn/an/aUndeclared sulfoaildenafilRecallDrugs 10/18/2011A-Slim 100% Natural Slimming CapsuleH&S GMP Factoryn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Health Slimming CoffeeVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Leisure 18 Slimming CoffeeVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011P57 HoodiaHuikng Pharmaceuticaln/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Magic Slim Weight Reduction CapsuleVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Sheng Yuan FangVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011PhentraBurn Slimming CapsulesVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011TengdaVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Acai Berry Soft Gel ABCVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Fruit Plant Lossing Fat CapsuleVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Botanical SlimmingVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Pai You Guo Slim TeaVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 10/18/2011Lose Weight CoffeeVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011DaiDaiHuaJiaoNangVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 10/18/2011Advanced Slim 5Various Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Magic Slim TeaVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Ja Dera 100% Natural Weight Loss SupplementVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/18/2011Slender Slim 11Various Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 10/03/2011Uprizing 2.0Superior Metabolic Technologies IncMarietta, GAn/aUndeclared superdrol, a synthetic steroidRecallDrugs 07/08/2011Meizitang Botanical Slimming 100% Natural Soft GelIntercharm Inc.Fort Lauderdale, FLn/aUndeclared sibutraminePublic NotificationDrugsRecall07/08/2011Slim Forte Slimming CoffeeIntercharm Inc.Fort Lauderdale, FLn/aUndeclared sibutraminePublic NotificationDrugsRecall07/08/2011Slim Forte Slimming CapsulesIntercharm Inc.Fort Lauderdale, FLn/aUndeclared sibutraminePublic NotificationDrugsRecall07/08/2011Slim Forte Slimming CapsuleLA Beauty Store, Inc.n/an/aUndeclared sibutraminePublic NotificationDrugs 07/08/2011Slim Forte Double Power Slimming CapsulesLA Beauty Store, Inc.n/an/aUndeclared sibutraminePublic NotificationDrugs 05/29/2011ViaXtremeVarious Distributorsn/an/aUndeclared sulfoaildenafilPublic NotificationDrugs 05/10/2011Slim Xtreme Herbal Slimming CapsuleGlobe All Wellness, LLC2854 Stirling Rd Suite G Hollywood, FL 33020n/aUndeclared sibutraminePublic NotificationDrugsRecall04/28/2011RegenerectEthos Environmental, Inc.n/an/aUndeclared sulfoaildenafilRecallDrugs 03/28/2011THE BEST Enhancement SupplementAVNS Incn/an/aUndeclared sulfoaildenafilRecallDrugs 03/25/2011Male EnhancerUSA Far Ocean Group Inc.1609 W. Valley Blvd., #338, Alhambra, CA 91803n/aUndeclared tadalafilRecallDrugs 03/25/2011X-HeroUSA Far Ocean Group Inc.1609 W. Valley Blvd., #338, Alhambra, CA 91803n/aUndeclared sulfosildenafilRecallDrugs 03/22/2011U-ProstaUSA Far Ocean Group Inc.1609 W. Valley Blvd., #338, Alhambra, CA 91803n/aUndeclared terazosinRecallDrugs 03/16/2011Black AntVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 02/24/2011RegenErectRegeneca, Inc.n/an/aUndeclared tadalafilRecallDrugs 02/22/2011Extenze TabletsBiotab Nutraceuticals, Inc.n/an/aUndeclared tadalafil and sildenafilRecallDrugsNews Release02/11/2011Svelte 30 Svelte 30 Nutritional ConsultantsKissimmee, FLsvelte.comUndeclared sibutramineRecallDrugs 01/31/2011Reduce Weight Fruta PlantaGodi International, Corp.FLn/aUndeclared sibutramineRecallDrugs 01/31/2011Fruta PlantaGodi International, Corp.FLn/aUndeclared sibutramineRecallDrugs 01/18/2011Nite Rider Maximum Sexual Enhancer For MenKanec USA Incn/an/aUndeclared sildenafilRecallDrugs 01/18/2011STUD Capsule for MenKanec USA Incn/an/aUndeclared sildenafilRecallDrugs 01/12/2011Celerite Slimming CapsulesShaping Beauty, Inc.Southampton, PAceleriteweightloss.com; shapingbeauty.comUndeclared sibutraminePublic NotificationDrugsRecall01/03/2011Reduce Weight Fruta PlantaPRock Marketing LLCN/Afrutaplanta.comUndeclared sibutramineRecallDrugs 12/30/2010Passion CoffeeDrive Total Energyn/adrivetotalenergy.comUndeclared sulfoaildenafilPublic NotificationDrugs 12/30/2010RockHard ExtremeDrive Total Energyn/adrivetotalenergy.comUndeclared sulfoaildenafilPublic NotificationDrugs 12/22/2010Fruta PlantaPRock Marketing LLCn/afrutaplanta.comUndeclared sibutraminePublic NotificationDrugsRecall12/22/2010Pandora RockHard Laboratoriesn/an/aUndeclared analogue of SildenafiRecallDrugs 12/22/2010RockHard WeekendRockHard Laboratoriesn/an/aUndeclared analogue of SildenafiRecallDrugs 12/15/2010Man Up NowSynergy Distribution LLCn/an/aUndeclared sulfoaildenafilNews ReleaseDrugs 11/19/2010Vigor-25Piston Corp.n/an/aUndeclared sildenafilNews ReleaseDrugs 10/27/2010Duro Extend Capsules For MenIntelli Health Products80 Southwest 8th Street Miami, FL 33130n/aUndeclared sulfoaidenafilRecallDrugsExpanded Recall10/08/2010Slimming Beauty Bitter Orange Slimming CapsulesBeautiful Health Inc.n/an/aUndeclared sibutramineNews ReleaseDrugs 10/07/2010Novedex XTGaspari Nutrition Incorproated575 Prospect Street - Suite 230, Lakewood, NJn/aContains 3,17-keto-etiocholetriene, also known as ATDNews ReleaseDrugs 09/16/2010Arom-X CapsulesAdvanced Muscle Science4590 Deodar St., Silver Springs, Nevada 89429n/aContains 1,4,6 etioallocholan-dione, also known as ATDRecallDrugs 09/16/2010Arom-X UTT LiquidAdvanced Muscle Science4590 Deodar St., Silver Springs, Nevada 89429n/aContains 1,4,6 etioallocholan-dione, also known as ATDRecallDrugs 09/16/2010Arom-XL LiquidAdvanced Muscle Science4590 Deodar St., Silver Springs, Nevada 89429n/aContains 1,4,6 etioallocholan-dione, also known as ATDRecallDrugs 09/16/20104-AD CapsulesAdvanced Muscle Science4590 Deodar St., Silver Springs, Nevada 89429n/aContains 1,4,6 etioallocholan-dione, also known as ATDRecallDrugs 09/16/2010Decavol CapsulesAdvanced Muscle Science4590 Deodar St., Silver Springs, Nevada 89429n/aContains 1,4,6 etioallocholan-dione, also known as ATDRecallDrugs 09/16/2010ReversitolTribravus Enterprises, LLC d/b/a/ iForce Nutrition, LLC1305 Hot Spring Way #103, Vista CA 92081n/aContains 6-Etioallochol-1,4-Diene-3,17-Dione, also known as ATDRecallDrugs 09/15/2010Off Cycle II HardcoreFizogen Precision Technologies3133 Fortune Way, Suite #4, Wellington, FL 33414n/aContains 3,17-keto-etiochol-triene, also known as ATDRecallDrugs 09/14/2010ClomedKiloSports Inc.Phoenix, AZn/aUndeclared aromatase inhibitorRecallDrugs 09/13/2010ArimaDexGenetic Edge TechnologiesPhoenix, AZn/aUndeclared aromatase inhibitorNews ReleaseDrugs 08/25/2010TimeOut CapsulesVarious Distributorsn/an/aUndeclared hydroxythiohomosildenafilNews ReleaseDrugs 08/18/2010Mr. Magic Male Enhancer from Don WandsGlow Industries, Inc.Perrysburg, OHn/aUndeclared hydroxythiohomosildenafil and sulfoaildenafilRecallDrugs 08/10/2010Stiff NightsNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010AziffaNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010Size MattersNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010ErexNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010MojoNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010Hard DriveNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010EyefulNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010Red MagicNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010Straight UpNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010ZotrexNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010Monster ExcyteNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010WOWNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010XaitrexNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010VerectNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010ProlatisNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010XytamaxNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010MaxyteNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010LibidinalNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010OMGNovacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010OMG45Novacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/10/2010Zilex (with Golden Spear)Novacare LLCSalt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/09/2010Prolatis'Prolatis'Salt Lake City, UTn/aUndeclared sulfoaildenafilRecallDrugs 08/06/2010Solo Slim®EZVille, Ltd.Ronkonkoma, NYn/aUndeclared didesmethyl sibutramineRecallDrugs 08/06/2010Revivexxx® Extra StrengthEZVille, Ltd.Ronkonkoma, NYn/aUndeclared tadalafilRecallDrugs 07/28/2010Ejaculoid XXTREMENutraloid Labs Inc.Kingston, NYn/aUndeclared sulfoaildenafilRecallDrugs 07/28/2010Stimuloid IINutraloid Labs Inc.Kingston, NYn/aUndeclared sulfoaildenafilRecallDrugs 07/22/2010Joyful Slim Herb SupplementJ & H Besta Corp.Hicksville, NYn/aUndeclared desmethyl sibutramineRecallDrugs 07/16/2010Slim-30 Herb SupplementJ & H Besta Corp.Hicksville, NYn/aUndeclared N-desmethyl sibutramineRecallDrugsExpanded Recall07/16/2010Vialipro Good Health, Inc.Canutillo, TXn/aUndeclared sulfoaildenafilRecallDrugs 07/08/2010Que SheVarious Distributorsn/an/aUndeclared fenfluramine, propanolol, sibutramine, ephedrineRecallDrugs 06/19/2010Magic Power CoffeeINZ DISTRIBUTORS INC./MAGIC POWER COFFEE INC.Brooklyn, NYn/aUndeclared hydroxythiohomosildenafilNews ReleaseDrugs

Recall

Consumer Update

06/04/2010Rock Hard WeekendAtlas Operations, Inc.325 Sw 15th Ave, Pompano Beach, FL 33069-3246n/aCGMP for Drugs/Manufacture, Processing, Packing, Holding/AdulteratedWarning LetterDrugs 06/04/2010On Cycle II HardcoreAtlas Operations, Inc.325 Sw 15th Ave, Pompano Beach, FL 33069-3246n/aCGMP for Drugs/Manufacture, Processing, Packing, Holding/AdulteratedWarning LetterDrugs 06/04/2010Sleep Quick StripsAtlas Operations, Inc.325 Sw 15th Ave, Pompano Beach, FL 33069-3246n/aCGMP for Drugs/Manufacture, Processing, Packing, Holding/AdulteratedWarning LetterDrugs 06/04/2010Sleep Once AgainAtlas Operations, Inc.325 Sw 15th Ave, Pompano Beach, FL 33069-3246n/aCGMP for Drugs/Manufacture, Processing, Packing, Holding/AdulteratedWarning LetterDrugs 06/04/2010Sleep EaseAtlas Operations, Inc.325 Sw 15th Ave, Pompano Beach, FL 33069-3246n/aCGMP for Drugs/Manufacture, Processing, Packing, Holding/AdulteratedWarning LetterDrugs 06/04/2010InsomnixAtlas Operations, Inc.325 Sw 15th Ave, Pompano Beach, FL 33069-3246n/aCGMP for Drugs/Manufacture, Processing, Packing, Holding/AdulteratedWarning LetterDrugs 06/04/2010Musclextreme Pump ExtremeAtlas Operations, Inc.325 Sw 15th Ave, Pompano Beach, FL 33069-3246n/aCGMP for Drugs/Manufacture, Processing, Packing, Holding/AdulteratedWarning LetterDrugs 06/04/2010Derma-TropinAtlas Operations, Inc.325 Sw 15th Ave, Pompano Beach, FL 33069-3246n/aCGMP for Drugs/Manufacture, Processing, Packing, Holding/AdulteratedWarning LetterDrugs 06/04/2010GH.X Growth Hormone ExtremeAtlas Operations, Inc.325 Sw 15th Ave, Pompano Beach, FL 33069-3246n/aCGMP for Drugs/Manufacture, Processing, Packing, Holding/AdulteratedWarning LetterDrugs 04/20/2010VitalexVitapro, Inc.CAn/aUndeclared acetildenafil-analog News ReleaseDrugs 04/12/2010Amour Again for HimAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 04/12/2010ErectziaAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 04/12/2010Ere-xxx by Elite BodyAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 04/12/2010Ere-xxx by Maxi ElitAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 04/12/2010Stamin ItAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsWarning Letter04/12/2010Vigor 100Atlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 04/12/2010Whatz Up RxAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 04/02/2010Stud CapsuleKanec USA Inc.5061 South State Road 7. Ste 602, Davie FL 33314n/aUndeclared sildenafilRecallDrugs 03/30/2010MasXtremeNatural Wellness Inc.440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441n/aUndeclared aildenafil and phentolamine; undeclared aminotadalafil RecallDrugsExpanded Recall01/15/2010Advanced Muscle Science DienedroneMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Advanced Muscle Science LiquidroneMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Anabolic Formulation M1, 4ADMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Anabolic Formulations 1, 4 ADMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Anabolic Xtreme Hyperdrol X2MuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Anabolic Xtreme 3-ADMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010BCS Labs Testra-FlexMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Competitive Edge Labs M-DrolMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Competitive Edge Labs P-PlexMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Competitive Edge Labs X-TrenMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/20104Ever Fit D-DrolMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Gaspari Novedex XTMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Gaspari Halodrol LiquigelsMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010iForce 1,4 AD BOLD 200MuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010iForce MethaDROLMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010iForce DymethazineMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 01/15/2010Monster CapsMuscleMaster.com, Inc.Northborough, MAn/aContains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 12/11/2009Aspire OneAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsWarning Letter12/11/2009Sex EnhancerAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 12/11/2009StaminilAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafil RecallDrugs

Expanded Recall

Warning Letter

12/11/2009Sexual SurgeAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009Love FuelAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009VaxitrolAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009Love Fuel 2Atlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 12/11/2009ErexaAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009ZenerectAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafil RecallDrugsExpanded Recall12/11/2009ArousinAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/200972 HoursAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs

Expanded Recall

Warning Letter

12/11/2009Bulk- UnlabeledAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 12/11/2009EnhancementAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009Red Hot SexAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009LibiplusAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009ErexxxAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 12/11/2009TacktolAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009Amour for himAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 12/11/2009ErousaAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009RockhardAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugs 12/11/2009EzerexAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009TopvirilAtlas Operations, Inc.Pompano Beach, FLn/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009VierectAtlas Operations, Inc.n/an/aUndeclared sulfoaildenafilRecallDrugs

Expanded Recall

Warning Letter

12/11/2009APLAtlas Operations, Inc.n/an/aUndeclared sulfoaildenafilRecallDrugs 12/11/2009ClyamaxAtlas Operations, Inc.n/an/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009Rainbow RocketAtlas Operations, Inc.n/an/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009Finally On DemandAtlas Operations, Inc.n/an/aUndeclared sulfoaildenafilRecallDrugs

Expanded Recall

Warning Letter

12/11/2009XtremexciteAtlas Operations, Inc.n/an/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall12/11/2009WhatzupAtlas Operations, Inc.n/an/aUndeclared sulfoaildenafilRecallDrugs 12/11/2009Depth ChargeAtlas Operations, Inc.n/an/aUndeclared sulfoaildenafilRecallDrugsExpanded Recall11/12/2009Pai You GuoGMP Herbal Products, Inc.Westminster, CA n/aUndeclared sibutramine and phenolphthaleinRecallDrugs 11/12/2009BromodrolIDS Sportsn/an/aUndeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”RecallDrugs 11/12/2009Dual Action Grow TabsIDS Sportsn/an/aUndeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”RecallDrugs 11/12/2009Grow TabsIDS Sportsn/an/aUndeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”RecallDrugs 11/12/2009Mass TabsIDS Sportsn/an/aUndeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”RecallDrugs 11/12/2009Ripped Tabs TRIDS Sportsn/an/aUndeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”RecallDrugs 11/09/2009RockHard WeekendRockHard Laboratories Atlanta, GAn/aUndeclared sulfoaildenfilRecallDrugs 11/03/20094Ever Fit D-DrolBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Advanced Muscle Science DienedroneBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Advanced Muscle Science Liquidrone UTTBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Anabolic Xtreme Hyperdrol X2Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009APS (aka Advanced Muscle Science) MastavolBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009APS (aka Advanced Muscle Science) RevampBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009APS (aka Advanced Muscle Science) Ultra Mass StackBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009APS (aka Advanced Muscle Science) Ripped StackBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Better Body Sports FinadexBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Black China Labs Straight DrolBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Black China Labs Straight PhlexedBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Body Conditioning Solutions TestraFLEXBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Bjorklund MethyldrostanoloneBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009BOSC Enterprises Epi-TrenBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009BOSC Enterprises Magna DrolBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Chaparral Labs EpivolBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Chaparral Labs Pheravol-VBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Competitive Edge Labs M-DrolBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Competitive Edge Labs P-PlexBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Competitive Edge Labs X-trenBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Diabolic Labs Epio-PlexBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Diabolic Labs Finabolic 50Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Diabolic Labs Revenge Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Ergopharm 6-OXO Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Ergopharm 6-OXO Extreme Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009EST (aka Engineered Sports Technology) MethAnstance Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Extreme Labs Susto-Test Depot Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Fizogen ON Cycle II Hardcore Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009G.E.T/ (Genetic Edge Technologies) SUS-500 Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugsNews Release11/03/2009G.E.T/ (Genetic Edge Technologies) Tren-250 Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Hardcore Formulations T-Roid Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009I Force Nutrition 1,4 AD Bold 200 Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009I Force Dymethazine/Reversitol Combo Pack Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009I Force Reversitol Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009I Force Nutrition 17a PheraFLEX Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009I Force Nutrition Dymethazine Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009I Force Nutrition Methadrol Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugsNews Release11/03/2009IDS (aka Innovative Delivery Systems) Bromodrol Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009IDS (aka Innovative Delivery Systems) Grow Tabs TR Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009IDS (aka Innovative Delivery Systems) Mass Tabs Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009IDS (aka Innovative Delivery Systems) Oxodrol Pro Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009IDS (aka Innovative Delivery Systems) Ripped Tabs TR Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009IDS (aka Innovative Delivery Systems) Rapid Release Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Ripped Tabs Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Kilo Sports Massdrol Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Kilo Sports Phera-Mass Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Kilo Sports Trenadrol Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids,, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Monster Caps Monster Caps Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Myogenix Spawn Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Nutra Coastal D-Stianozol Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugsNews Release11/03/2009Nutra Coastal H-Drol Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Nutra Coastal MDIT Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Nutra Coastal S-Drol Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Nutra Coastal Trena Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Performance Anabolics Methastadrol Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Performance Anabolics Tri-Methyl X Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Purus Labs E-pol Inslinsified Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Purus Labs Nasty Mass Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Rage RV2 Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Rage RV3 Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Rage RV4 Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Rage RV5 Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugsNews Release11/03/2009Redefine Nutrition Finaflex 550-XD Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Redefine Nutrition Finaflex Ripped Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Transform Supplements Forged Extreme Mass Bodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 11/03/2009Transform Supplements Forged Lean MassBodybuilding.com, LLCBoise, IDbodybuiliding.comMay contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"RecallDrugs 09/23/2009Pineapple Fat Reducing Slimming CapsulePlatinum Strategies Inc1500 N, Curry Pike, Bloomington, IN 47404911healthshop.comUndeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/MisbrandedWarning LetterDrugsClose-out Letter09/23/2009Tomato Slimming (Lose Weight)Platinum Strategies Inc1500 N, Curry Pike, Bloomington, IN 47404911healthshop.comUndeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/MisbrandedWarning LetterDrugsClose-out Letter09/23/2009Slim UpPlatinum Strategies Inc1500 N, Curry Pike, Bloomington, IN 47404911healthshop.comUndeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/MisbrandedWarning LetterDrugsClose-out Letter09/23/2009Fresh Lemon Slimming (Xian Ning Meng Shou Shen)Platinum Strategies Inc1500 N, Curry Pike, Bloomington, IN 47404911healthshop.comUndeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/MisbrandedWarning LetterDrugsClose-out Letter09/23/2009Slim Quick Result 3 in 1Platinum Strategies Inc1500 N, Curry Pike, Bloomington, IN 47404911healthshop.comUndeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/MisbrandedWarning LetterDrugsClose-out Letter09/23/2009Perfect Combination Balishou CapsulePlatinum Strategies Inc1500 N, Curry Pike, Bloomington, IN 47404911healthshop.comUndeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/MisbrandedWarning LetterDrugsClose-out Letter09/23/2009Apple SlimPlatinum Strategies Inc1500 N, Curry Pike, Bloomington, IN 47404911healthshop.comUndeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/MisbrandedWarning LetterDrugsClose-out Letter09/23/2009Shoufsy Activity GirlPlatinum Strategies Inc1500 N, Curry Pike, Bloomington, IN 47404911healthshop.comUndeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/MisbrandedWarning LetterDrugsClose-out Letter08/21/2009STEAMNutracoastal Trading LLCFreeport, NYn/aUndeclared tadalafilRecallDrugs 07/28/2009S-DROLNutracoastal Trading LLCFreeport, NYn/aUndeclared tadalafilRecallDrugs 07/27/2009TREN-XtremeAmerican Cellular Labs117 Arcadia Drive, Pacifica, CA 94044americell-labs.comContains 19-Norandrosta-4,9-diene-3,17 diene; Dietary Supplements/Adulterated/MisbrandedWarning LetterDrugs 07/27/2009MASS XtremeAmerican Cellular Labs117 Arcadia Drive, Pacifica, CA 94044americell-labs.comContains 17α-methyl-etioallocholan-2-ene-17b-01; Dietary Supplements/Adulterated/MisbrandedWarning LetterDrugs 07/27/2009ESTRO XtremeAmerican Cellular Labs117 Arcadia Drive, Pacifica, CA 94044americell-labs.comContains 4-hydroxyandrostenedione (4-0HA); Dietary Supplements/Adulterated/MisbrandedWarning LetterDrugs 07/27/2009AH-89-XtremeAmerican Cellular Labs117 Arcadia Drive, Pacifica, CA 94044americell-labs.comContains 5a-androstano[3,2-c]pyrazole-3-one-17B-01-THP-ether; Dietary Supplements/Adulterated/MisbrandedWarning LetterDrugs 07/27/2009HMG XtremeAmerican Cellular Labs117 Arcadia Drive, Pacifica, CA 94044americell-labs.comContains 2a,3a-epithio-17a-methyl-17~-hydroxy-5a-etioallocholane; Dietary Supplements/Adulterated/MisbrandedWarning LetterDrugs 07/27/2009MMA-3 XtremeAmerican Cellular Labs117 Arcadia Drive, Pacifica, CA 94044americell-labs.comContains Androsta-1 ,4-dien-3, 17-dione; Dietary Supplements/Adulterated/MisbrandedWarning LetterDrugs 07/27/2009VNS-9 XtremeAmerican Cellular Labs117 Arcadia Drive, Pacifica, CA 94044americell-labs.comContains 17a-methyl-4-chloro-androsta-1,4-diene-3B, 17B-diol,1-androsteron; Dietary Supplements/Adulterated/MisbrandedWarning LetterDrugs 07/27/2009TT-40-XtremeAmerican Cellular Labs117 Arcadia Drive, Pacifica, CA 94044americell-labs.comContains 1-androsterone; Dietary Supplements/Adulterated/MisbrandedWarning LetterDrugs 07/15/2009LibieXtremeOpteron 1 Inc. dba Nature & Health Co.Brea, CAn/aUndeclared aminotadafilRecallDrugs 07/15/2009Y-4everOpteron 1 Inc. dba Nature & Health Co.Brea, CAn/aUndeclared sulfoaidenafilRecallDrugs 07/15/2009Libimax X LiquidOpteron 1 Inc. dba Nature & Health Co.Brea, CAn/aUndeclared aminotadafilRecallDrugs 07/15/2009Powermania LiquidOpteron 1 Inc. dba Nature & Health Co.Brea, CAn/aUndeclared sulfoaidenafilRecallDrugs 07/15/2009Powermania CapsuleOpteron 1 Inc. dba Nature & Health Co.Brea, CAn/aUndeclared sulfoaidenafilRecallDrugs 07/15/2009Herbal DisiacOpteron 1 Inc. dba Nature & Health Co.Brea, CAn/aUndeclared sulfoaidenafilRecallDrugs 07/15/2009One Weight Loss Pill Young You Corporation19590 Ventura Blvd., Tarzana, CAn/aUndeclared sibutramineRecallDrugs 07/15/2009SlimDemand CapsulesYoung You Corporation19590 Ventura Blvd., Tarzana, CAn/aUndeclared sibutramineRecallDrugs 07/15/2009Botanical Weight LossYoung You Corporation19590 Ventura Blvd., Tarzana, CAn/aUndeclared sibutramineRecallDrugs 07/13/2009Libipower PlusHalotecoLos Angeles, CAn/aUndeclared tadalafilRecallDrugs 06/15/2009Stamina-RxHi-Tech Pharmaceuticals, Inc.6015-B Unity Dr., Norcross, GA 30071n/aUndeclared benzamidenafilRecallDrugs 04/27/2009LibimaxOpteron 1 Inc. dba Nature & Health Co.Brea, CAn/aUndeclared tadalafilRecallDrugs 04/20/2009Slim 3in1 M-18 ROYAL DIETUniversal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 04/20/2009Extrim Plus 24 Hours RE-BURN FormulaUniversal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 04/20/2009Slim 3in1 EXTRA SLIM FORMULAUniversal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 04/20/2009Slim 3in1 EXTRA SLIM WAIST FORMULAUniversal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 04/20/2009Perfect Slim 100% Natural Herbal EssenceUniversal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 04/20/2009BODY SHAPINGUniversal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 04/20/2009SLIM FAST 2Universal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 04/20/2009SLIM FASTUniversal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 04/20/2009SlimBurnUniversal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 04/20/2009TRIM PLUS 2Universal ABC Beauty Supply International, Inc.Brooklyn, NYn/aUndeclared sibutramineRecallDrugs 03/11/2009Zencore PlusBodee LLCCentury City, CAn/aUndeclared benzamidenafilRecallDrugs 01/29/2009Venom Hyperdrive 3.0Applied Lifescience Research Industries Inc. (ALR Industries)Oak View, CAn/aUndeclared sibutramineNews ReleaseDrugs 12/22/20082 Day DietVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/20082 Day Diet Slim AdvanceVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/20082x Powerful SlimmingVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/20083 Day DietVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/20083 Days FitVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/20083x Slimming PowerVarious Distributorsn/an/aUndeclared sibutramine and phenytoinQ&ADrugsRecall12/22/20085x Imelda Perfect SlimmingVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/20087 Day Herbal SlimVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/20087 Days DietVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/20087 DietVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/20087 Diet Day/Night FormulaVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/20088 Factor DietVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinQ&ADrugs 12/22/2008Eight Factor Diet Various Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/200821 Double SlimVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/200824 Hours DietVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinQ&ADrugsRecall12/22/2008999 Fitness EssenceVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008BioEmagrecimVarious Distributorsn/an/aUndeclared fenproporex; fluoxetine and furosemideQ&ADrugs 12/22/2008Body CreatorVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Body ShapingVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Body SlimmingVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Cosmo SlimVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Extrim PlusVarious Distributorsn/an/aUndeclared sibutramine and phenytoinQ&ADrugs 12/22/2008Extrim Plus 24 Hour Reburn Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Fasting DietVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Fatloss SlimmingVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinQ&ADrugs 12/22/2008GMP Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Herbal Xenicol Various Distributorsn/an/aUndeclared cetilistatQ&ADrugs 12/22/2008Imelda Fat ReducerVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Imelda Perfect SlimVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinQ&ADrugsRecall12/22/2008JM Fat ReducerVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Lida DaiDaihuaVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Meili Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Meizitang Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Miaozi MeiMiaoQianZiJiaoNangVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Miaozi Slim CapsulesVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Natural ModelVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Perfect Slim Various Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Perfect Slim 5x Various Distributorsn/an/aUndeclared sibutramine and phenolphthaleinQ&ADrugs 12/22/2008Perfect Slim UpVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Phyto ShapeVarious Distributorsn/an/aUndeclared rimonabantQ&ADrugs 12/22/2008Powerful SlimVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008ProSlim PlusVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Reduce WeihgtVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Royal Slimming FormulaVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinQ&ADrugsRecall12/22/2008Sana PlusVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Slim 3 in 1Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Slim 3 in 1 Extra Slim FormulaVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Slim 3 in 1 Extra Slim Waist FormulaVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Slim 3 in 1 M18 Royal Diet Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Slim 3 in 1 Slim FormulaVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Slim BurnVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Slim Express 4 in 1Various Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Slim Express 360Various Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Slim TechVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Slim UpVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Slim Waist FormulaVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Slim WaistlineVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008SlimbionicVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Sliminate Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Slimming FormulaVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Somotrim Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Starcaps Various Distributorsn/an/aUndeclared bumetanideQ&ADrugs 12/22/2008Super Fat Burner Various Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Superslim Various Distributorsn/an/aUndeclared sibutramine and phenolphthaleinQ&ADrugs 12/22/2008Super SlimmingVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugsRecall12/22/2008Trim 2 PlusVarious Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Triple Slim Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Venom Hyperdrive 3.0Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Waist Strength Formula Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Xsvelten Various Distributorsn/an/aUndeclared sibutramineQ&ADrugs 12/22/2008Zhen de ShouVarious Distributorsn/an/aUndeclared sibutramine and phenolphthaleinQ&ADrugs 11/26/2008STARCAPS DIET SYSTEMBalanced Health Products, Inc.n/an/aUndeclared bumetanide RecallDrugsExpanded Recall11/23/2008Zhen de Shou Fat LossFashion SanctuarySan Diego, CAn/aUndeclared sibutramineRecallDrugs 07/23/2008ViaproEG Labs, LLCNew York, NY Undeclared  thio-methisosildenafilRecallDrugs 07/01/2008Rize 2 The OccasionJack Distribution, LLC; G & N works, Inc.; Devine Distribution, Inc1501 Green Road Unit C Pompano Beach, FLn/aUndeclared thiomethisosildenafilRecallDrugsExpanded Recall07/01/2008Rose 4 HerJack Distribution, LLC; G & N works, Inc.; Devine Distribution, Inc1501 Green Road Unit C Pompano Beach, FLn/aUndeclared thiomethisosildenafilRecallDrugsExpanded Recall05/29/2008Viril-Ity-Power (VIP) TabsInternational Pharmaceuticals, Ltd.P.O. Box 5165, Bradford, MA 01835n/aUndeclared hydroxyhomosildenafilRecallDrugs 05/27/2008Xiadafil VIP TabsSEI PharmaceuticalsMiami, FLn/aUndeclared hydroxyhomosildenafilNews ReleaseDrugs 03/31/2008MaxidusKG Enterprises LLCPO Box 5156, El Dorado Hills, CA 95742n/aUndeclared sildenafil and tadalafilRecallDrugs 03/25/2008Blue SteelActive Nutraceuticals; Marion GroupCarrollton, GAn/aUndeclared substances that are similar in chemical structure to sildenafilNews ReleaseDrugs 03/25/2008HeroActive Nutraceuticals; Marion GroupCarrollton, GAn/aUndeclared substances that are similar in chemical structure to sildenafilNews ReleaseDrugs 02/28/2008Aspire36Palo Alto Labs265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984n/aUndeclared aildenafil and dimethyl sildenafil thione (sulfoaildenafil)RecallDrugs 02/28/2008Aspire LitePalo Alto Labs265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984n/aUndeclared aildenafil and dimethyl sildenafil thione (sulfoaildenafil)RecallDrugs 12/28/2007Super ShangaiShangai Distributor, Inc.Coamo, Puerto Ricon/aUndeclared sildenafil analoguesRecallDrugs 12/28/2007Strong TestisShangai Distributor, Inc.Coamo, Puerto Ricon/aUndeclared sildenafil analoguesRecallDrugs 12/28/2007Shangai UltraShangai Distributor, Inc.Coamo, Puerto Ricon/aUndeclared sildenafil analoguesRecallDrugs 12/28/2007Shangai Ultra XShangai Distributor, Inc.Coamo, Puerto Ricon/aUndeclared sildenafil analoguesRecallDrugs 12/28/2007Lady ShangaiShangai Distributor, Inc.Coamo, Puerto Ricon/aUndeclared sildenafil analoguesRecallDrugs 12/28/2007Shangai Regular (Shangai Chaojimengnan)Shangai Distributor, Inc.Coamo, Puerto Ricon/aUndeclared sildenafil analoguesRecallDrugs 12/28/2007Naturalë Super PlusShangai Distributor, Inc.Coamo, Puerto Ricon/aUndeclared APIs for erectile dysfunctionConsumer UpdateDrugs 11/21/2007Encore TabsBodee LLCAvenue of the Stars, 702E, Century City, CA 90067n/aUndeclared aminotadalafilRecallDrugs 09/12/2007Axcil TWC Global, LLC530 Showers Drive, Suite 7-129, Mountain View, CA 94040n/aUndeclared sildenafil, sulfosildenafil and sulfohomosildenafilRecallDrugs 09/12/2007DesirinTWC Global, LLC530 Showers Drive, Suite 7-129, Mountain View, CA 94040n/aUndeclared sildenafil, sulfosildenafil and sulfohomosildenafilRecallDrugs 08/31/2007Zencore TabsBodee LLCAvenue of the Stars, 702E, Century City, CA 90067n/aUndeclared aminotadalafil, sulfosildenafil, sulfohomosildenafilRecallDrugs 08/17/2007METABOSLIMTM Apple Cider VinegarConfidence Inc.Port Washington, NYn/aUndeclared sibutramineRecallDrugs 06/14/2007Long WeekendConfidence Inc.Port Washington, NYn/aUndeclared tadalafilRecallDrugs 04/17/2007H S Joy of LoveJen-On Herbal Science International, Inc.205 Russell St., City of Industry, CA 91744n/aUndeclared piperadino vardenafilRecallDrugs 03/16/2007Rhino Max (Rhino V Max)Cosmos Trading, Inc.543 Olympic Blvd, Suite # 419, Los Angeles, CA 90015n/aUndeclared aminotadalafilSafety AlertDrugsRecall