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  1. Health Fraud Scams

Health Fraud Product Database

This list includes unapproved products that have been subject to FDA health fraud* related violations. These products have been cited in warning letters, online advisory letters, recalls, public notifications, and press announcements for issues varying from products marketed as dietary supplements claiming to cure, mitigate, treat or prevent disease, to the use of undeclared ingredients or new dietary ingredients.

This list only includes a small fraction of the potentially hazardous products marketed to consumers online and in retail establishments. Even if a product is not included in this list, consumers should exercise caution before using certain products. 

For more information, see the Medication Health Fraud and Health Fraud Scams webpages. 

Search Database

(Table results update automatically as you type)
DateProduct1FirmFirm AddressSource/URL(s)SubjectActionProgram Area(s)Additional Outcome
12/27/2024Natural 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 
12/03/2024New Me n/an/aShopnewmeroot.comContains undeclared yellow oleanderAlertFoods 
12/03/2024VidaSlimMotivate Me Ashley, LLCSan Antonio, TXVidaslim Co./Vidaslim USAContains undeclared yellow oleanderAlertFoodsRecall
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 NotificationDrugsRecall
11/19/2024HON-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 500mln/an/aamazon.com; www.walmart.comUndeclared tadalafilPublic NotificationDrugs 
11/06/2024PeakMax CapsulesVitalityVitaSacramento, CAvitalityvita.comUndeclared sildenafil and diclofenacRecallDrugsPublic Notification
11/06/2024VitalityXtra CapsulesVitalityVitaSacramento, CAvitalityvita.comUndeclared sildenafilRecallDrugsPublic Notification
11/04/2024ZapMax CapsulesBoulla LLCSacramento, CAamazon.comUndeclared sildenafil and diclofenacRecallDrugsPublic Notification
11/04/2024ZoomMax CapsulesBoulla LLCSacramento, CAamazon.comUndeclared sildenafil and diclofenacRecallDrugsPublic Notification
10/30/2024Nhan Sam Tuyet Lien Truy Phong Hoann/aFlushing, NYbuy-herbal.comUndeclared chlorpheniramine, dexamethasone and furosemidePublic NotificationDrugsRecall
10/30/2024ITCHA 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, CAebay.com, etsy.comUndeclared acetaminophen and diclofenacPublic NotificationDrugsRecall
09/05/2024Amazyn/an/avarious websites, including SoloVital, Main Products and Amazon, and in some retail storesUndeclared diclofenac and omeprazoleDrug AlertDrugsPublic Notification
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 Wann/an/aeverymarket.comUndeclared dexamethasone and chlorpheniraminePublic NotificationDrugs

Warning Letter

Recall

07/10/2024Gold Hard Steel PlusSupercore Products GroupAtlanta, GAhardsteelusa.comUndeclared sildenafilPublic NotificationDrugsRecall
07/05/2024Hard SteelSupercore Products GroupAtlanta, GAhardsteelusa.comUndeclared sildenafil and acetaminophenPublic NotificationDrugsRecall
06/28/2024Diamond ShruumzProphet Premium BlendsSanta Ana, CAdiamondshruumz.comProducts contain MuscimolRecallFoodsInvestigation of Illnesses
06/20/2024Infla-650Guru Inc.Lilburn, GAnutraherbusa.com; nutra650.comUndeclared acetaminophen, diclofenac and phenylbutazonePublic NotificationDrugsRecall
06/14/2024Umaryn/an/asolovital.com; Main Products, Inc.Undeclared diclofenac and omeprazolePublic NotificationDrugs

Recall

Additional Recall

Warning Letter

Drug Alert

06/14/2024La Paixn/an/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 
04/17/2024Ossos-Sansn/an/ahttps://alnaturaleshop.comUndeclared diclofenac and methocarbamolPublic NotificationDrugsWarning Letter
04/05/2024Eva Nutrition Mexican Tejocote rootGlobal Mix, Inc.New Yorketsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.comContains undeclared yellow oleanderRecallFoods 
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 NotificationDrugsRecall
01/30/2024SchwinngToday the World; STOP CLOPEZ CORPn/aschwinnng.com; amazon.comUndeclared nortadalafilPublic NotificationDrugsRecall; Additional Recall
01/30/2024Sustain®Today the Worldn/asustainformula.com; amazon.comUndeclared tadalafil and avanafilPublic NotificationDrugsRecall
01/26/2024nwl 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 oleanderAlertFoodsRecall
01/26/2024H & Natural Brazil SeedH and Naturaln/ahandnatural.comContains undeclared yellow oleanderAlertFoodsRecall
01/26/2024ALIPOTEC Tejocote Root Raiz de TejocoteBackstage CTC Sellern/aamazon.comContains undeclared yellow oleanderAlertFoodsRecall
01/26/2024ALIPOTEC 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 
01/05/2024Blue 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 263
Carriere, MS 39426
https://blueboyherbs.comNew DrugOnline Advisory LetterFoods; Drugs 
01/02/2024ENDUREAn/an/aamazon.comUndeclared tadalafil and sildenafilPublic NotificationDrugs 
01/02/2024ForeverMenn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugsRecall
01/02/2024Seraphim Zn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugs 
12/26/2023Wild Bulln/an/aamazon.comUndeclared nortadalafilPublic NotificationDrugs 
12/26/2023TO THE MOONn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugsRecall
12/26/2023T XTRA Strength Test Boostern/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 
12/26/2023Ram Itn/an/aamazon.comUndeclared sildenafilPublic NotificationDrugsRecall
12/21/2023Govvi 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 NotificationDrugsRecall
11/17/2023Tepee Herbal Tean/an/aamazon.comUndeclared piroxicamPublic NotificationDrugs 
11/17/2023Notoginseng Formula Special Gout Granule8th Avenue Pharmacyn/aebay.comUndeclared dexamethasone and diclofenacPublic NotificationDrugsRecall
11/03/2023Dr. Ergin's SugarMD Advanced Glucose Supportn/an/asugarmds.comUndeclared Glyburide and MetforminPublic NotificationDrugsRecall
10/19/2023The RockNoah’s Wholesale, LLCn/an/aUndeclared sildenafilPublic NotificationDrugsRecall
09/29/2023Reumo Flexn/an/abotanical-be.comUndeclared diclofenacPublic NotificationDrugsRecall
09/29/2023Kuka Flex Forten/an/abotanical-be.comUndeclared diclofenacPublic NotificationDrugsRecall
08/31/2023Tapee 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 NotificationDrugsRecall
08/22/2023X 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/ahttps://burhealthy.comNew drugsOnline Advisory LetterFoods; Drugs 
05/08/2023New Fast-Act Rheumatism Capsulen/an/aVariousUndeclared indomethacinPublic NotificationDrugs 
05/08/2023UA-Blockn/an/aVariousUndeclared indomethacinPublic 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 
05/11/2023V=GRA GOLD 500mgn/an/aVariousUndeclared sildenafilPublic NotificationDrugs 
05/08/2023Fast-Act Rheuma Capsulen/an/aVariousUndeclared prednisone-21-acetate and piroxicamPublic NotificationDrugs 
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 methocarbamolPublic 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 NotificationDrugsRecall
02/02/2023MANNERS Energy Boostn/an/aamazon.comUndeclared tadalafilPublic NotificationDrugs 
12/21/2022B.B. Clear Dark Spot Remover Creamn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022Amos Make Me White in 7 Daysn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022African Queen Strong Bleaching Treatmentn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022Light & Natural CAROTONE Black Spot Corrector CREME B.S.Cn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022HIYADY Glutatione Cream White & Brightn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022Aneeza Gold Beauty Face Creamn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022Collagen Plus - Vit E Cream, Night Creamn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022Skin care & Cosmetic MSII Express Peelingn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022Skin care & Cosmetic MSII Whitening Peelingn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022Ling Zhi BB Whitening Creamn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022La Tia Mana Crema Limpiadora y Curativan/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022Be Be Special Creamn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022Be Be Special Cream CCM/Yellown/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022CCM Perfect 365 White Creamn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
12/21/2022CCM Special Cream Turmericn/an/aVariousSkin Product with Mercury and/or HydroquinonePublic NotificationCosmetics/Drugs 
11/21/2022JACK'D Sexual Enhancement Liquidn/an/aVariousUndeclared sildenafilPublic NotificationDrugs 
11/21/2022JACK'D Sexual Enhancement Capsulesn/an/aVariousUndeclared sildenafilPublic NotificationDrugs 
11/14/2022ArterosilCalroy Health Sciences, LLC14362 N Frank Lloyd Wright, Suite 1000 Scottsdale, AZ 85260arterosil.comNew Drug/MisbrandedWarning LetterFoods 
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-5Healthy Trends Worldwide, LLC11011 Spring Point Cir Riverview, FL 33579-4303goldenafter50.comNew Drug/MisbrandedWarning LetterFoods 
11/14/2022Blood Pressure SupportChambers' 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 
11/14/2022CholestAidEssential 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 Notification
07/28/2022Honeymoon Exclusive For Men & Womenn/an/aExamination of imported goodsUndeclared tadalafil and sildenafilPublic NotificationDrugs 
07/25/2022SustangoUltra Supplement LLCWilmington, DEamazon.comUndeclared tadalafilRecallDrugs 
07/22/2022Lipopastilla + Gold Maxn/an/alipopastillas.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 
07/15/2022Adam's Secret Extra Strength Bluen/an/aadamssecret.comUndeclared tadalafilPublic 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 Letter
04/25/2022Secret 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.comUndeclared tadalafilPublic NotificationDrugs 
04/25/2022X Rated Honey for Men1am USA Incorporated dba Pleasure Products USA6603 Crimson Lane Barnhart, MO 63012pleasureproductsusa.com; amazon.comUndeclared tadalafilPublic NotificationDrugsWarning Letter
04/20/2022Ortiga Mas Ajo Rey Extra Forten/an/aebay.comUndeclared diclofenac, dexamethasone and methocarbamolPublic NotificationDrugsAlert
04/20/2022Ortiga Mas Ajo Reyn/an/aamazon.comUndeclared diclofenacPublic NotificationDrugsAlert
04/20/2022Artri 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 capsulesABC 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 capsulesEsupplementsales, LLCn/aamazon.comUndeclared tadalafilRecallDrugs 
01/07/2022Tawon LiarVarious Distributorsn/aetsy.comUndeclared meloxicamPublic NotificationDrugs 
01/05/2022Artri Ajo KingVarious Distributorsn/aamazon.comUndeclared diclofenacPublic NotificationDrugs 
01/02/2022NasitrolAmcyte 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 Release
12/08/2021Brahma Male EnhancementVarious Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugsNews Release
12/08/2021Hard AF!Various Distributorsn/awalmart.comUndeclared sildenafil and acetaminophenPublic NotificationDrugsNews Release
12/08/2021Helmi’s Honey VIPVarious Distributorsn/awalmart.comUndeclared tadalafilPublic NotificationDrugsNews Release
12/08/2021Jaguar PowerVarious Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugsNews Release
12/08/2021Kangaroo Intense Alpha 3000Various Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugsNews Release
12/08/2021Magnum XXL 9800Various Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugsNews Release
12/08/2021Pink PussycatVarious Distributorsn/awalmart.comUndeclared sildenafilPublic NotificationDrugs

News Release

Recall

12/08/2021Go On RedVarious Distributorsn/awalmart.comUndeclared tadalafilPublic NotificationDrugsNews Release
12/01/2021“VitaStik” product lineVitaStik, Inc.433 N. Camden Dr. #600, Beverly Hills, CA 90210vitastik.comUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information
12/01/2021“VitaCig products”VitaCig, Inc.2375 Watermill Dr., Orange Park, FL 32073vitaciggroup.comUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information
12/01/2021“vaporizer” and “diffuser” productsNV Nutrition, LLC4700 140th Ave N. Suite 112, Clearwater, FL 33762nutriair.comUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information
12/01/2021“B12 VITAMINVAPE”Vitamin Vape, Inc.6320 S. Sandhill Road, Suite 5, Las Vegas, NV 89120vitaminvape.coUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information
12/01/2021“Caffeine Pen”Eagle Energy USA, Inc.27 N. 27th Street, Suite 2102, Billings, MT 59101-2347eagle.energyUnapproved New Drugs/MisbrandedWarning LetterDrugsMore Information
11/18/2021Crocin 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.comUnapproved New Drugs/MisbrandedWarning LetterDrugs 
09/07/2021CuraLinRadhanite, 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 SupportAr-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 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 
08/19/2021“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 PillsJe 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 
07/28/2021MelatoninDr. 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 NotificationDrugsRecall
07/26/2021“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 PlusAlpha 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 Letter
07/01/2021High 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 
07/01/2021FlexifyBiomedical 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

06/23/2021ProbioticXLGreat 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.comNew 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.comNew 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.comNew 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.comNew 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.comNew 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.comNew 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.onlineNew Drug/MisbrandedWarning LetterFoods 
04/21/2021Mega-Dose Vitamin CDRF LLCUnited Statesdoctorfarrah.com; drfarrah.onlineNew Drug/MisbrandedWarning LetterFoods 
04/21/2021Boston CDRF LLCUnited Statesdoctorfarrah.com; drfarrah.onlineNew 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 CollagenMolecular 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 SprayAllure 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% AlcoholNatural 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.comAdulterated 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.comAdulterated 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 ExtractDuoc 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 Release
02/18/2021MindSoothe CapsulesNative Remedies dba Silver Star Brands250 City Center, Oshkosh, WI 54906nativeremedies.comNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021Mood SupportMountain Peak Nutritionals9953 SW Arctic Dr., Beaverton, OR 97005mountainpeaknutritionals.comNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021Natural Anxiety & Depression ReliefWholesome Wellness6804 NE 79th Court, Portland, OR 97218wholesome-wellness.comNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021Mood Boosting ProbioticLifted Naturals1101 Mulberry St, A2 Suite 10, Kansas City, MO 64101liftednaturals.comNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021“Enlifta Mood Elevator”Enlifta, LLC16372 Page St., Omaha, NE 68118enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/New Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021“Enlifta Anxiety”Enlifta, LLC16372 Page St., Omaha, NE 68118enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/New Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021St. John’s WortBlossom Nature, LLC1193 Elederberry Circle, Folsom, CA 95630blossom-nature.com; amazon.com/Supplement-National-Antidepressant-Support-Provides-Relief-120/dp/B082TTLJGPNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021Full Spectrum™ St. John's Wort ExtractProHealth Inc.555 Maple St, Carpinteria, CA 93013prohealth.comNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021Dr. Garber's Depression ReliefDr. Garber’s Natural Solutions2607 2nd St #1, Santa Monica, CA 90405drgarbers.comNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021Inositol 100% Pure Free FormFDC Nutrition Inc.2313 East Philadelphia Street Ste L, Ontario, CAfdcnutrition.comNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021Sleep Sana “Sleep Drops”SANA Group LLC1200 E. Woodhurst S-200, Springfield, MO 65804sleepsana.comNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021Sleep Sana “Sleep Shots”SANA Group LLC1200 E. Woodhurst S-200, Springfield, MO 65804sleepsana.comNew Drug/MisbrandedWarning LetterFoodsNews Release
02/18/2021“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 NotificationDrugsRecall
01/19/2021Adam’s Secret Extra Strength 3000 PlatinumVarious Distributorsn/aadamssecret.coUndeclared tadalafil and sildenafilPublic NotificationDrugsRecall
01/14/2021“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 Letter
01/14/2021“Golden Milk Electuary”Sage Moon Apothecary LLC40 Main Street, Seal Harbor, ME 04675sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaineNew Drug/MisbrandedWarning LetterFoodsCloseout Letter
01/14/2021“Beyond Elderberry Syrup”Sage Moon Apothecary LLC40 Main Street, Seal Harbor, ME 04675sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaineNew Drug/MisbrandedWarning LetterFoodsCloseout Letter
01/12/2021Allicin 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 
12/22/2020SynotrexSpeedwinds 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 befitaholicn/aebay.comUndeclared phenolphthaleinPublic NotificationDrugsNews Release
12/17/2020Premier 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 Release
12/17/2020Poseidon Platinum 3500Various Distributors; including seller Yamtun7n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs

News Release

Recall

12/17/2020Mero MachoVarious Distributors; including seller setec24n/aebay.comUndeclared tadalafilPublic NotificationDrugsNews Release
12/17/2020Gold LionVarious Distributors; including seller unityhealthn/aebay.comUndeclared sildenafilPublic NotificationDrugsNews Release
12/17/2020White PantherVarious Distributors; including seller qualmart1-9n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugsNews Release
12/17/2020Triple Wicked PlatinumVarious Distributors; including seller pricemasters_usan/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugsNews Release
12/17/2020The Super Panther 77kVarious Distributors; including seller qualmart1-9n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugsNews Release
12/17/2020Royal HoneyVarious Distributors; including seller ahmedjamilmuslimn/aebay.comUndeclared tadalafilPublic NotificationDrugsNews Release
12/17/2020PremierZen 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 qualmart1-9n/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugsNews Release
12/17/2020Black Stallion 9000Various Distributors; including seller qualmart1-9n/aebay.comUndeclared tadalafilPublic NotificationDrugsNews Release
12/17/2020Lishou Slimming CoffeeVarious Distributors; including seller annday14n/aebay.comUndeclared sibutramine and desmethylsibutraminePublic NotificationDrugsNews Release
12/17/2020Li Da Daidaihua PlusVarious Distributors; including seller micki_jayn/aebay.comUndeclared phenolphthaleinPublic NotificationDrugsNews Release
12/17/2020Imperla Elita VitaccinoVarious Distributors; Recall by Dash Xclusiven/aebay.comUndeclared sibutramine and fluoxetinePublic NotificationDrugs

News Release

Recall

12/17/2020Fruta PlantaVarious Distributors; including seller aialoj0n/aebay.comUndeclared sibutraminePublic NotificationDrugsNews Release
12/17/2020Fruta BioVarious Distributors; including seller frutabion/aebay.comUndeclared sibutramine and phenolphthaleinPublic NotificationDrugsNews Release
12/17/2020Super SlimVarious Distributors; including seller emmcli0n/aebay.comUndeclared sibutramine and desmethylsibutraminePublic NotificationDrugsNews Release
12/15/2020“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.comFinished Pharmaceuticals/Unapproved new drugWarning LetterFoods 
12/10/2020“Ginger Oil”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.comFinished Pharmaceuticals/Unapproved new drugWarning LetterFoods 
12/10/2020“Dandelion root Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.comFinished Pharmaceuticals/Unapproved new drugWarning LetterFoods 
12/10/2020“Echinacea purpurea Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.comFinished Pharmaceuticals/Unapproved new drugWarning LetterFoods 
12/10/2020“Antispasmodic Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.comFinished Pharmaceuticals/Unapproved new drugWarning LetterFoods 
12/10/2020“Ginger Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.comFinished Pharmaceuticals/Unapproved new drugWarning LetterFoods 
12/10/2020“Cayenne Tincture”Prairie Dawn Herbs4250 S. Calhan Hwy Yoder, CO 80864-9669prairiedawnherbs.comFinished 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.comNew Drug/MisbrandedWarning LetterFoods 
12/09/2020“Body Detox (Oral Spray)”Bodyhealth.com, LLC707 Cleveland St. Clearwater, FL 33755-4107bodyhealth.comNew Drug/MisbrandedWarning LetterFoods 
12/09/2020“Omega 3 Health”Bodyhealth.com, LLC707 Cleveland St. Clearwater, FL 33755-4107bodyhealth.comNew 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 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Red Water GrassSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020SarsaparillaSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Marsh MarigoldSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Sea Moss/Irish MossSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Dog BloodSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Guava LeafSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Jack in the BushSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020King of the ForestSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020ETHIOPIAN ABISH (FENNUGREEK SEED PWD.)Sundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Ethiopian Traditional Talba (Flaxseed Meal Cereal)Sundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Fever GrassSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Jamaican Milk WissSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Spanish NeedleSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Fig LeafSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020DiabeticsSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Flax Seed Oil & Honey BlendSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Bitter Kola (Arogbo)Sundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Jamaican Bissy PowderSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Ghanian Black SpiceSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Piss A BedSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020White Pond LilySundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Purple SageSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Quassia WoodSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Trumpet LeafSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020White JointaSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020White SageSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Guinea Hen WeedSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Sundial Cassava MealSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Cocoa BallsSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020African Fever BushSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Mojo BushSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Blood LeafSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Wood & Root TonicSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020KoromanteeSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020AshantiSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020African Manback TonicSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020PimentoSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Mitmitta (Cayenne Pepper)Sundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Mahogany BarkSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Chaney RootSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Cerasee Bay Leaves, Mango BarkSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020AsthmaSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Blood PressureSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020HeartSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Worms and ParasitesSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Flu-Allergies /HayFeverSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020ArthritisSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Axum Traditional Ethiopian Honey BeverageSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Black SageSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Black WissSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020CinnamonSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Palo De BrazilSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Broom WeedSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Bread NutSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Jamaican and Tropical Raw HoneySundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Hemp Seed OilSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Talibah’s Tooth Powder and Ethiopian CoffeeSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
07/09/2020Blue VervainSundial Herbal Products3609 Boston Road, Bronx, NYsundialherbs.com/sundialMisbranding & Unapproved New DrugsRecallFoods 
05/20/2020Sterile Cannabidiol (CBD) previously listed as Cannabidiol (CBD) ComplexBiota Biosciences, LLCSeattle, WAn/aUnapproved new drug; injectable products marketed without FDA approvalRecallDrugs 
05/20/2020Sterile Curcumin previously listed as Curcumin Complex 4 10 mLBiota Biosciences, LLCSeattle, WAn/aUnapproved new drug; injectable products marketed without FDA 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 LetterFoodsRecall
05/11/2020“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 LetterDrugsRecall
05/11/2020“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 LetterDrugsRecall
05/06/2020NAD+ 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 NotificationDrugs 
02/05/2020Alpha-MaleVarious Distributorsn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 
02/05/2020RMFLEXVarious Distributorsn/aebay.comUndeclared diclofenacPublic NotificationDrugs 
02/05/2020OrgaZEN Gold 5800Various Distributorsn/aamazon.comUndeclared sildenafilPublic NotificationDrugs 
12/18/2019U-Dream LiteVarious Distributorsn/aamazon.comUndeclared eszopiclone and zopiclonePublic NotificationDrugs 
12/18/2019U-Dream Full NightVarious Distributorsn/aamazon.comUndeclared eszopiclone and zopiclonePublic NotificationDrugs 
12/17/2019SUPER Platinum 30000 RHINO 7Motto International Corp.n/an/aUndeclared tadalafilPublic NotificationDrugs 
12/17/2019SUPER Platinum 30000 PANTHERMotto International Corp.n/an/aUndeclared tadalafilPublic NotificationDrugs 
12/17/2019SUPER Platinum 30000 STALLIONMotto International Corp.n/an/aUndeclared sildenafil, tadalafil, and dapoxetinePublic NotificationDrugs 
12/17/2019SUPER Platinum 30000 BULLMotto International 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 Letter
10/17/2019Skinny PillLose Fat Gain Life M&B4102 Orange Ave Ste 118 & 119, Long Beach, CA 90807losefatgainlifemb.comUndeclared 1,3-dimethylamylamine (DMAA)Public NotificationFoodsWarning Letter
10/16/2019UP2Various Distributorsn/ahmherbs.comUndeclared sildenafilPublic NotificationDrugsRecall
10/09/2019CHUVarious 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 53-18
09/26/2019Golden Pearl Beauty CreamGolden Pearl Cosmetics115/1 M , Quaid-e-Azam Industrial Estate , Kot Lakhpat, Lahore, Punjab Pakistann/aFound to contain 12 g/kg of mercuryAlertDrugsImport Alert 53-18
09/26/2019Chandni Whitening CreamSJ Enterprises222 CCA FF , DHA Phase 4 Sector CCA , Lahore, Punjab Pakistann/aFound to contain 8.79 g/kg of mercuryAlertDrugsImport Alert 53-18
09/26/2019Goree 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 53-18
09/26/2019Monespa 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 53-18
09/19/2019Green LumbarGL HoldingsNewport Beach, Californiagetgreenlumber.com; greenlumber.comUndeclared tadalafilPublic NotificationDrugsRecall
09/16/2019Macho 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 LetterFoods; Drugs 
07/25/2019Certified Organic FrankincenseBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 
07/25/2019High Blood Pressure SupportBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 
07/25/2019Moses Lip Balm-RoseBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 
07/25/2019Moses Lip Balm-NaturalBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 
07/25/2019Fix It AllBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 
07/25/2019Moses OilsBible Healing Oils111 5th Avenue East Buckeye, AZ 85326biblehealingoils.netUnapproved New DrugsOnline Advisory LetterFoods; Drugs 
07/25/2019Moses 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 TinctureCuraleaf, Inc.301 Edgewater Place Suite 405, Wakefield, MA 01880curaleafhemp.comUnapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 
07/22/2019CBD Pain-Relief PatchCuraleaf, Inc.301 Edgewater Place Suite 405, Wakefield, MA 01880curaleafhemp.comUnapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 
07/22/2019CBD LotionCuraleaf, Inc.301 Edgewater Place Suite 405, Wakefield, MA 01880curaleafhemp.comUnapproved New Drugs/Misbranded/Cannabidiol (CBD) ProductsWarning LetterDrugs 
07/16/2019Reduktis MaxVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
07/16/2019Black StormVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2019Big PenisVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2019Boss Lion 9000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2019De Guo Heijin GangVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2019Herb ViagraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2019La Pepa NegraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2019Odimafo Powerful Tablet 200 mgVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2019Plant VigraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2019ShengjingpianVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2019Vigour 800 mgVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/01/2019Lipro Dietary CapsuleVarious Distributorsn/aliprodietpill.comUndeclared tadalafilPublic NotificationDrugs 
06/26/2019Adelgasin PlusVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and N-desmethyl sibutraminePublic NotificationDrugs 
06/26/2019Super Slimming HerbVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
06/26/2019Lishou Fuling JiaonangVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and N-desmethyl sibutraminePublic NotificationDrugs 
06/26/2019Detoxi SlimVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
06/26/2019Absolute Nine SlimVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and N-desmethyl sibutraminePublic NotificationDrugs 
06/26/2019Peru MacaVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
06/26/2019Germany Black GorillaVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
06/25/201912 Gram Kratom Powder SamplesCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Borneo yellow Vein KratomCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Bali Kratom PowderCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Cali's Best Premium Powder MixCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Cali's Premium Special Reserve Kratom PowderCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Enhanced Maeng Da CapsulesCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Green Malay Kratom CapsCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Kratom Capsule SamplesCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Full Spectrum 50x Kratom TinctureCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Super Enhanced Bali KratomCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/25/2019Super Enhanced Maeng Da KratomCali Botanicals, LLC500 Sibley Street, Folsom, CA 95630calibotanicals.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
06/23/2020Anti-Viral Immune Enhancement CapsulesGolden Nutrition Inc.Opa Locka, FLgoldennutrition.comUnsubstantiated Health Claims on LabelRecallFoods 
06/06/2019SpiroNILPRL, Inc.84 West Fourth Avenue, Lobelville, TN 37097-3267forestcenterherbs.comCGMP/Dietary Supplement/Adulterated/MisbrandedWarning LetterFoods 
06/06/2019General FormulaPRL, Inc.84 West Fourth Avenue, Lobelville, TN 37097-3267forestcenterherbs.comCGMP/Dietary Supplement/Adulterated/MisbrandedWarning LetterFoods 
06/06/2019Black WalnutPRL, Inc.84 West Fourth Avenue, Lobelville, TN 37097-3267forestcenterherbs.comCGMP/Dietary Supplement/Adulterated/MisbrandedWarning LetterFoods 
06/06/2019Alfalfa Herbal TonicPRL, Inc.84 West Fourth Avenue, Lobelville, TN 37097-3267forestcenterherbs.comCGMP/Dietary Supplement/Adulterated/MisbrandedWarning LetterFoods 
06/06/2019Kidney Formula #1PRL, Inc.84 West Fourth Avenue, Lobelville, TN 37097-3267forestcenterherbs.comCGMP/Dietary Supplement/Adulterated/MisbrandedWarning LetterFoods 
06/06/2019Kidney Formula #2PRL, Inc.84 West Fourth Avenue, Lobelville, TN 37097-3267forestcenterherbs.comCGMP/Dietary Supplement/Adulterated/MisbrandedWarning LetterFoods 
06/06/2019MicroNILPRL, Inc.84 West Fourth Avenue, Lobelville, TN 37097-3267forestcenterherbs.comCGMP/Dietary Supplement/Adulterated/MisbrandedWarning LetterFoods 
05/22/2019Man Fuel Xtreme EditionVarious Distributorsn/agomanfuel.comUndeclared sildenafil, dithiodesmethyl carbodenafil and desmethyl carbodenafilPublic NotificationDrugs 
05/22/2019Man Fuel Male Enhancement Shooter (Tropical Fruit Flavor)Various Distributorsn/agomanfuel.comUndeclared tadalafil and desmethyl carbodenafilPublic NotificationDrugs 
05/16/2019Green Bali PowderKratomNC925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335kratomnc.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
05/16/2019Red Indo PowderKratomNC925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335kratomnc.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
05/16/2019Gold Bali PowderKratomNC925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335kratomnc.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
05/16/2019White Indo PowderKratomNC925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335kratomnc.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
05/16/2019Super White PowderKratomNC925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335kratomnc.comUnapproved New Drug/MisbrandedWarning LetterDrugs 
05/15/2019Active Herb YinViveActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Active Herb Ease TonicActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Active Herb LiverViveActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang Vertigoff (Ban Xia Bai Zhu Tian Ma Pian)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang Nasopass (Bi Yan Pian)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang NeuroSoothe (Chai Hu Long Gu Lu Mu Li Pian (Wan)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang JointsJoy (Du Huo Ji Sheng Wan)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang Cardiovigor (Fu Fang Dan Shen Pian)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang Kudzu Relaxe (Ge Gen Tang Pian)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang Stomacare (Huo Xiang Zheng Qi Pian)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang Breathmooth (Ke Chuan Pian)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang Stonepass (Li Shui Pai Shi Pian)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/15/2019Guang Ci Tang Bupleuri Relaxe (Xiao Chai Hu Pian (Wan)ActiveHerb Technology, Inc.8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263activeherb.comUnapproved New Drugs/MisbrandedWarning LetterFoods 
05/07/2019Topical Sunscreen and Anti-Blemish Over-the-Counter (OTC) Drug ProductsAMMD Labs, LLC1501 Green Rd Ste J, Pompano Beach, FL 33064n/aCGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 
05/07/2019The BEAST CapsulesSTIFF BOY LLCn/an/aUndeclared sildenafilRecallDrugs 
05/02/2019Puriton Eye Relief DropsKadesh International7341 Lincoln Way, Garden Grove, CA 92841puriton.usCGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 
05/02/2019Puriton Intimate Disinfection SprayKadesh International7341 Lincoln Way, Garden Grove, CA 92841puriton.usCGMP/Finished Pharmaceuticals/AdulteratedWarning LetterDrugs 
04/23/2019Fever~InfectionNewton Laboratories Inc DBA Newton Homeopathics455 Gees Mill Business Ct. NE, Conyers, GA 30013newtonlabs.netCGMP/Finished Pharmaceuticals/Adulterated/MisbrandedWarning LetterDrugs 
04/23/2019Food Allergies~AdditivesNewton Laboratories Inc DBA Newton Homeopathics455 Gees Mill Business Ct. NE, Conyers, GA 30013newtonlabs.netCGMP/Finished Pharmaceuticals/Adulterated/MisbrandedWarning LetterDrugs 
04/23/2019Blues~Mood~EmotionsNewton Laboratories Inc DBA Newton Homeopathics455 Gees Mill Business Ct. NE, Conyers, GA 30013newtonlabs.netCGMP/Finished Pharmaceuticals/Adulterated/MisbrandedWarning LetterDrugs 
04/23/2019Vaccination~IllnessNewton Laboratories Inc DBA Newton Homeopathics455 Gees Mill Business Ct. NE, Conyers, GA 30013newtonlabs.netCGMP/Finished Pharmaceuticals/Adulterated/MisbrandedWarning LetterDrugs 
04/09/2019Platinum 40000SD Imports, LLCn/an/aUndeclared sildenafilRecallDrugs 
04/05/2019Kopi Jantan Tradisional Natural Herbs CoffeeBrian Richardson dba In Tha Pinkn/an/aUndeclared sildenafiland tadalafilRecallDrugs 
03/22/2019LEOPARD Miracle HoneyUSA LESSPO Box 250-138, Brooklyn, NY 11225n/aUndeclared sildenafilRecallDrugs 
03/21/2019BLUEFUSION CapsulesAta Int. Inc.n/an/aUndeclared sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzeinRecallDrugs 
02/08/2019Indian HerbMcDaniel Life-Line LLCn/an/aMarketed without an approved NDA/ANDARecallDrugs 
01/29/2019Silver Bullet 10xNature's Rxn/an/aUndeclared sildenafil and tadalafilRecallDrugs 
01/28/2019GoLean DetoxGoLean Detox US4832 Central Ave, Charlotte, NC 28205-5844facebook.com/GoLean-detox-US-1592137147568285/Undeclared sibutramine and phenolphthaleinPublic NotificationDrugsWarning Letter
01/28/2019Ultra FitVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and N-desmethylsibutraminePublic NotificationDrugs 
01/28/2019Slimmer Extreme Thermogenic FormulaVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 
01/28/2019Slim Bio CapsulesVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine, N-desmethylsibutramine, sildenafil, tadalafil, benproperine and diphenhydraminePublic NotificationDrugs 
01/28/2019SliminaVarious Distributorsn/aeffectivehealthyproducts.comUndeclared sibutraminePublic NotificationDrugs 
01/28/2019Red Stallion Extra StrongVarious Distributorsn/aInternational Mail ShipmentsUndeclared tadalafilPublic NotificationDrugs 
01/28/2019Natural V=GRAVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafil and tadalafilPublic NotificationDrugs 
01/28/2019Yong GangVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafil and tadalafilPublic NotificationDrugs 
01/28/2019Golden AntVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
01/28/2019Instinct Best Sexual EnjoymentVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
01/28/2019Nectar Del AmorVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
01/10/20131 Day DietVarious Distributorsn/an/aUndeclared N-desmethylsibutraminePublic NotificationDrugs 
01/10/2019Black King KongVarious Distributorsn/aInternational Mail ShipmentsUndeclared moroxydine and sildenafilPublic NotificationDrugs 
01/10/2019The Silver BulletVarious Distributorsn/aebay.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 
01/08/2019Rhino 5KHappy Together, Inc.504 Muirfield Dr., Atlantis FL, 33462n/aUndeclared sildenafil and tadalafilRecallDrugs 
12/10/2018On DemandVarious Distributorsn/agoodlifeondemand.comUndeclared sildenafilPublic NotificationDrugs 
11/30/2018Willy Go WildVarious Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 
11/30/2018MOB CandyVarious Distributorsn/an/aUndeclared sildenafil and tadalafilPublic NotificationDrugs 
11/21/2018America TreasureVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/08/2018Memory RevitalizerAlzheimer's Corporation (ALZcorp)6000 Uptown Blvd., NE Suite 308 Albuquerque, NM 87110lifeimagined.com; alzheimerscorp.com; memoryrevitalizer.com; alzcorp.comNew drugsOnline Advisory LetterFoods; Drugs 
11/08/2018Cerebara GPC (L-Alpha glycerophosphocholine)Alzheimer's Corporation (ALZcorp)6000 Uptown Blvd., NE Suite 308 Albuquerque, NM 87110lifeimagined.com; alzheimerscorp.com; memoryrevitalizer.com; alzcorp.comNew drugsOnline Advisory LetterFoods; Drugs 
11/08/2018Life ImaginedAlzheimer's Corporation (ALZcorp)6000 Uptown Blvd., NE Suite 308 Albuquerque, NM 87110lifeimagined.com; alzheimerscorp.com; memoryrevitalizer.com; alzcorp.comNew drugsOnline Advisory LetterFoods; Drugs 
11/08/2018Mind and Memory SupportAlzheimer's Organization509 Riverside Drive, Suite 302 Stuart, FL 34994alzheimersorganization.orgNew drugsOnline Advisory LetterFoods; Drugs 
11/08/2018Leopard Secret Miracle HoneyVarious Distributorsn/aExamination of imported goodsUndeclared sildenafilPublic NotificationDrugs 
11/08/2018Best Leopard Miracle of HoneyVarious Distributorsn/aExamination of imported goodsUndeclared sildenafil and tadalafilPublic NotificationDrugs 
11/08/2018Gold Max BlueVarious Distributorsn/agoldmaxblue.comUndeclared sildenafilPublic NotificationDrugs 
11/07/2018BALI GreensDr. Fitt Intelligent Designs, LLC812 S Georgia St Amarillo, TX 79106drfitt.com; drfittinfo.comNew DrugsOnline Advisory LetterFoods; DrugsWarning Letter
11/07/2018BALI PurplesDr. Fitt Intelligent Designs, LLC812 S Georgia St Amarillo, TX 79106drfitt.com; drfittinfo.comNew DrugsOnline Advisory LetterFoods; DrugsWarning Letter
11/07/2018Black Seed OilDr. Fitt Intelligent Designs, LLC812 S Georgia St Amarillo, TX 79106drfitt.com; drfittinfo.comNew DrugsOnline Advisory LetterFoods; DrugsWarning Letter
11/07/2018DHEA CapsulesDr. Fitt Intelligent Designs, LLC812 S Georgia St Amarillo, TX 79106drfitt.com; drfittinfo.comNew DrugsOnline Advisory LetterFoods; DrugsWarning Letter
11/07/2018Lugol’s Solution 2% DropsDr. Fitt Intelligent Designs, LLC812 S Georgia St Amarillo, TX 79106drfitt.com; drfittinfo.comNew DrugsOnline Advisory LetterFoods; DrugsWarning Letter
11/07/2018Robenyzme CapsulesDr. Fitt Intelligent Designs, LLC812 S Georgia St Amarillo, TX 79106drfitt.com; drfittinfo.comNew DrugsOnline Advisory LetterFoods; DrugsWarning Letter
11/07/2018OMG Max DropsDr. Fitt Intelligent Designs, LLC812 S Georgia St Amarillo, TX 79106drfitt.com; drfittinfo.comNew DrugsOnline Advisory LetterFoods; DrugsWarning Letter
11/07/2018New Dawn CapsulesDr. Fitt Intelligent Designs, LLC812 S Georgia St Amarillo, TX 79106drfitt.com; drfittinfo.comNew DrugsOnline Advisory LetterFoods; DrugsWarning Letter
11/07/2018Vitamin C with R-Lipoic AcidDr. Fitt Intelligent Designs, LLC812 S Georgia St Amarillo, TX 79106drfitt.com; drfittinfo.comNew DrugsOnline Advisory LetterFoods; DrugsWarning Letter
11/07/2018Aromatherapy for Dementia Memory Kit Premier EditionHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Aromatherapy for Dementia Memory Kit Second EditionHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Bodyguard Blend Essential OilHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018ClearMind Blend Essential OilHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Lavender Essential OilHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Attention Aromatherapy PatchHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Calming Aromatherapy PatchHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Lavender Aromatherapy PatchHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Perk Up Aromatherapy PatchHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Refresh Aromatherapy PatchHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Rested Aromatherapy PatchHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Aromatherapy Patch Sample PackHealthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store340 Royal Poinciana Way, #317 Palm Beach, FL 33480alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStoreNew DrugsOnline Advisory LetterFoods; Drugs 
11/07/2018Essential Oils including Dementia/Alzheimer's (Day) Synergy Oil and Dementia/Alzheimer's (Night) Synergy OilThis Wonderful Life New Age ShopM-0-7, Plaza Damas 60 Jalan Sri Hartamas 1 Kuala Lumpur, 50480 Malaysia MYtwlshop.comNew DrugsOnline Advisory LetterFoods; Drugs 
10/15/2018Zero XtremeFat Burners Zonen/an/aUndeclared sibutramineRecallDrugs 
10/01/2018FX75000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
10/01/2018Baschi Quick Slimming CapsuleVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and N-desmethylsibutraminePublic NotificationDrugs 
10/01/2018In ShapeVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
10/01/2018Like Slim CoffeeVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
10/01/2018Shengan Natural ModelVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
10/01/2018Green Lean Body CapsuleVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and N-desmethylsibutraminePublic NotificationDrugs 
10/01/2018Strong HorsesVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
10/01/2018USA for WomanVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
10/01/2018V-MaxVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
10/01/2018ProSolutionVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
09/06/2018PurblackAdaptive Energy LLC109 E 17th St. Ste 4, Cheyenne, WY 82001purblack.comNew Drug/MisbrandedWarning LetterFoodsClose-out Letter
08/31/2018Easy 2 SlimVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
08/31/2018Slimming CapsuleVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 
08/31/2018Extenze Nutritional SupplementVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
08/31/2018BodySlim HerbalVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
08/31/2018Extenze PlusVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
08/31/2018PremierZen Gold 4000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
08/31/20185KVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
08/31/2018Panther Power Platinum 11000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
08/31/2018NuvitraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and fluoxetinePublic NotificationDrugs 
08/31/2018XXXPlosion UltraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
08/29/2018Cell StopOptimal Health Knowledge LLC2177 NE 62nd Ct. Fort Lauderdale, FL 33308optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/New DrugsOnline Advisory LetterFoods; Drugs 
08/29/2018Cardio ForteOptimal Health Knowledge LLC2177 NE 62nd Ct. Fort Lauderdale, FL 33308optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/New DrugsOnline Advisory LetterFoods; Drugs 
08/29/2018Inflam-AlieveOptimal Health Knowledge LLC2177 NE 62nd Ct. Fort Lauderdale, FL 33308optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/New DrugsOnline Advisory LetterFoods; Drugs 
08/29/2018Liv AssistOptimal Health Knowledge LLC2177 NE 62nd Ct. Fort Lauderdale, FL 33308optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/New DrugsOnline Advisory LetterFoods; Drugs 
08/29/2018MindfulOptimal Health Knowledge LLC2177 NE 62nd Ct. Fort Lauderdale, FL 33308optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/New DrugsOnline Advisory LetterFoods; Drugs 
08/29/2018GI ComfortOptimal Health Knowledge LLC2177 NE 62nd Ct. Fort Lauderdale, FL 33308optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/New DrugsOnline Advisory LetterFoods; Drugs 
08/29/2018TranquilOptimal Health Knowledge LLC2177 NE 62nd Ct. Fort Lauderdale, FL 33308optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/New DrugsOnline Advisory LetterFoods; Drugs 
08/10/2018Ding Ji Wei GeVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/31/2018Black Rhino 25000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/31/2018Gold Rhino 25000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/31/2018Boss Rhino 15000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/31/2018Platinum Rhino 25000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/31/2018Krazzy RhinoVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/16/2018Rhino 8 Platinum 8000Various Distributorsn/an/aUndeclared N-desmethylsibutramine, phenolphthalein, diclofenac, and sildenafilPublic NotificationDrugs 
07/11/2018Platinum Maximum Strength Blue Pill VersionMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramine and phenolphthaleinRecallDrugsConsent Decree
07/11/2018Slimming Plus Advanced Weight LossMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sildenafilRecallDrugsConsent Decree
07/11/2018African ViagraMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sildenafilRecallDrugsConsent Decree
07/11/2018GINSENGMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sildenafilRecallDrugsConsent Decree
07/11/2018African SupermanMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sildenafilRecallDrugsConsent Decree
07/11/2018Old ChineseMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sildenafilRecallDrugsConsent Decree
07/11/2018Lean Extreme MaxMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramineRecallDrugsConsent Decree
07/11/2018X-treme Beauty SlimMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramineRecallDrugsConsent Decree
07/11/2018African Superman - Top-Class Permanence TabletMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sildenafilRecallDrugsConsent Decree
07/11/2018Slim EvolutionMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared diclofenacRecallDrugsConsent Decree
07/11/2018Fat Loss Slimming BeautyMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramine and phenolphthaleinRecallDrugsConsent Decree
07/11/2018Fruta PlantaMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared sibutramine and phenolphthaleinRecallDrugsConsent Decree
07/11/2018Botanical SlimmingMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared APIRecallDrugsConsent Decree
07/11/2018Slim BodyMyNicNaxs, LLC1012 Alpine Dr, Deltona, FL 32725mynicnaxs.com; ruglamourous.comUndeclared APIRecallDrugsConsent Decree
07/09/2018AsunsaVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine, N-desmethylsibutramine, benzylsibutramine, phenolphthalein and diclofenacPublic NotificationDrugs 
07/09/2018C.U. PlusVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafil and tadalafilPublic NotificationDrugs 
07/09/2018Lyn DTOX FS3Various Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and N-desmethylsibutraminePublic NotificationDrugs 
07/09/2018Dale MasVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafil and tadalafilPublic NotificationDrugs 
07/09/2018Grakcu CapsuleVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafil and tadalafilPublic NotificationDrugs 
07/09/2018Maximum PowerfulVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
07/03/2018Body Shape Weight LossVarious Distributorsn/aInternational Mail ShipmentsUndeclared phenolphthaleinPublic NotificationDrugs 
07/03/2018Row of Antibody PilVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine and phenolphthaleinPublic NotificationDrugs 
07/03/2018Chong Cao Qiang Shen WangVarious Distributorsn/aInternational Mail ShipmentsUndeclared phenolphthaleinPublic NotificationDrugs 
07/03/2018Adipotrim XTVarious Distributorsn/aInternational Mail ShipmentsUndeclared phenolphthaleinPublic NotificationDrugs 
07/03/2018MaxidusVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
06/20/2018Gold ViagraVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
06/20/2018AB SlimVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine, phenolphthalein and sildenafilPublic NotificationDrugs 
06/20/2018Adriana Balance SVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
06/20/2018Black Stallion 35000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
06/20/2018XXXPlosionVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
06/07/2018PAYA Dietary Supplement ProductVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
06/07/2018Crossroads Wellness BeverageUp Inya Gear22 Centennial St., Fairfield, PA 17320crossroads2freeedom.com; upinyabeverages.comNew Drug/MisbrandedWarning LetterFoodsClose-out Letter
05/18/2018SolaricarePharmacy Direct, PDU8 The Green, Suite 5871, Dover, DE 19901solaricare.comNew Drug/Labeling/MisbrandedWarning LetterFoodsClose-out Letter
05/17/20187KShoreside Enterprises, Inc.6345 Newtown Circle A-3, Tampa, FL 33615n/aUndeclared sildenafil and/or tadalafilRecallDrugs 
05/17/2018Poseidon 4500 (Extreme 1000 mg)Shoreside Enterprises, Inc.6345 Newtown Circle A-3, Tampa, FL 33615n/aUndeclared sildenafil and/or tadalafilRecallDrugs 
05/14/2018MediViral Extra Strength Herpes TreatmentMediViral, IncPO Box 56822 Los Angeles, CA 91413mediviral.com; twitter.com/mediviralNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018MediViral Extra Strength Herpes Topical TreatmentMediViral, IncPO Box 56822 Los Angeles, CA 91413mediviral.com; twitter.com/mediviralNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018Anti-StrokeOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018BonesOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018Viral-XOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018CandidaOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018Iron InfusionOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018Mental FocusOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018Natural Cancer FighterOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018Sugar Diabetes ControlOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018NiagraOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018“Honey, I’m Home” Body WashOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018“Ancient Healing Herbs” Body WashOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018“Cinnamon Sensations” Body WashOlivia’s Healing Herbs1102 Edgefield St. Killeen, TX 75649-2112oliviashealingherbs.comNew DrugsOnline Advisory LetterFoods; Drugs 
05/14/2018Best CandyVarious Distributorsn/aExamination of Imported GoodsUndeclared nortadalafilPublic NotificationDrugs 
03/28/2018Black Lion PillVarious Distributorsn/arakuten.comUndeclared sildenafilPublic NotificationDrugs 
03/28/2018Red Zone Xtreme 3000Various Distributorsn/aebay.comUndeclared tadalafilPublic NotificationDrugs 
03/28/2018Rhino 69 Extreme 50000AMA Wholesale Inc.n/abonanza.comUndeclared tadalafilPublic NotificationDrugsRecall
03/28/2018Blue Pearl All Natural Male Enhancement SupplementMarmex Corpn/an/aUndeclared sildenafilRecallDrugs 
12/06/2017After Gallbladder Removal KitGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Beet Root CapsulesGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/201730 Day Gallbladder SolutionGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Bile SaltsGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017CholineGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Dissolve GSGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Gallbladder ND DetoxGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Gallstone KitGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Glutathione Liposomal LiquidGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Liver Detox KitGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Liver ND DetoxGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Peppermint Oil CapsulesGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017TranquinolGallbladder Attackn/agallbladderattack.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Prostalgene Oral DropsProstalgene LLCn/aprostalgene.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Shilajit ResinHealthy Nutrition Group LLCn/anaturalshilajit.com; organicagsolutions.orgNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017NutriHoneyHealthy Nutrition Group LLCn/anaturalshilajit.com; organicagsolutions.orgNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Bulk ShilajitHealthy Nutrition Group LLCn/anaturalshilajit.com; organicagsolutions.orgNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Combination Herpes TreatmentSynergy Health Solutionsn/acure4herpes.com; treatment4herpes.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017L-LysineSynergy Health Solutionsn/acure4herpes.com; treatment4herpes.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017TribulusSynergy Health Solutionsn/acure4herpes.com; treatment4herpes.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017AstragalusSynergy Health Solutionsn/acure4herpes.com; treatment4herpes.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017RhodiolaSynergy Health Solutionsn/acure4herpes.com; treatment4herpes.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Amino Acid Formula (or “Unique Amino Formula”)Synergy Health Solutionsn/acure4herpes.com; treatment4herpes.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Curos EssentialCura Care, Inc.n/agetcuros.comNew DrugsOnline Advisory LetterFoods; Drugs 
12/06/2017Chill6Chill626 Valley Forge Cir. West Boylston, MA 01583chill6.comUnapproved New Drugs/MisbrandedOnline Advisory LetterDrugsWarning Letter
11/30/2017Chao JimengnanNutra Labs Inc.n/an/aUndeclared sildenafilPublic NotificationDrugs 
11/30/2017BullNutra Labs Inc.n/an/aUndeclared sildenafilPublic NotificationDrugs 
11/22/2017Asia Slim CapsulesVarious Distributorsn/aInternational Mail ShipmentsUndeclared sibutramine, diazepam, and bisacodylPublic NotificationDrugs 
11/20/2017New Stiff Nights Platinum 10kVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017Pro SolutionVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017QibianliVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017Rhino 11 Platinum 11000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017Rhino 12 Titanium 6000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017Rhino 25K 15000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017Rhino 69 Premium 8000Various Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017S.W.A.G. II Platinum 33KVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017V9 Male Sexual StimulantVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017TyrannosaurusVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017Fruta Planta Life (Garcinia Cambogia Premium)Various Distributorsn/aInternational Mail ShipmentsUndeclared sibutraminePublic NotificationDrugs 
11/20/2017Adipessum Miracle Slimming CapsulesVarious Distributorsn/aInternational Mail ShipmentsUndeclared fluoxetinePublic NotificationDrugs 
11/20/2017MenXtrongVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017Blue Diamond PillVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017Control CapsulesVarious Distributorsn/aInternational Mail ShipmentsUndeclared sildenafilPublic NotificationDrugs 
11/20/2017Blue Pearl All Natural Male EnhancementVarious Distributorsn/abluepearlformen.com; bluefusions.comUndeclared sildenafilPublic NotificationDrugs 
11/09/2017Hard Times for MenVarious Distributorsn/ablankterrmall.comUndeclared sildenafilPublic NotificationDrugs 
10/30/2017Linsen Double Caulis Plus (靈仙双藤素)Various Distributorsn/atranpharma.comUndeclared dexamethasonePublic NotificationDrugs 
10/10/2017Tiger 5000Various Distributorsn/aamazon.comUndeclared sildenafil and tadalafilPublic NotificationDrugs 
10/04/2017A1 SlimKiriko, LLCHouston, TXn/aUndeclared sibutramine, phenolphthalein and N-Desmethyl sibutramineRecallDrugs 
09/20/2017Vegetable VigraNatures Supplement, Inc.n/an/aUndeclared sildenafilRecallDrugs 
09/20/2017Rhino 7 Platinum 5000Gadget Island, Inc. dba Gear Islen/agearisle.comUndeclared sildenafil and tadalafilRecallDrugsExpanded Recall
09/20/2017Papa Zen 3300Gadget Island, Inc. dba Gear Islen/agearisle.comUndeclared sildenafil and tadalafilRecallDrugsExpanded Recall
09/20/2017Fifty Shades 6000Gadget Island, Inc. dba Gear Islen/agearisle.comUndeclared sildenafil and tadalafilRecallDrugsExpanded Recall
09/20/2017Grande X 5800Gadget Island, Inc. dba Gear Islen/agearisle.comUndeclared sildenafil and tadalafilRecallDrugsExpanded Recall
08/31/2017Physic Candy - DefineVarious Distributorsn/aphysic-candy.comUndeclared sibutraminePublic NotificationDrugs 
08/31/2017Physic Candy - CurveVarious Distributorsn/aphysic-candy.comUndeclared sibutraminePublic NotificationDrugs 
08/01/2017AMPT CoffeeThe AMPT Life, LLCn/aamptcoffee.comUndeclared sildenafil, tadalafil and milkPublic NotificationDrugs 
07/24/2017XplodeEZ Weight Loss TXCorpus Christi, TXn/aUndeclared sibutramineRecallDrugs 
07/24/2017La Bri's Body Health AtomicEZ Weight Loss TXCorpus Christi, TXn/aUndeclared sibutramineRecallDrugs 
07/17/2017Kingdom Honey for HimVarious Distributorsn/aInternational Mail ShipmentsUndeclared tadalafilPublic NotificationDrugs 
07/17/2017Kingdom Honey for HerVarious Distributorsn/aInternational Mail ShipmentsUndeclared tadalafilPublic NotificationDrugs 
07/17/2017Royal Honey VIPVarious Distributorsn/aInternational Mail ShipmentsUndeclared tadalafilPublic NotificationDrugs 
07/17/2017RHINO 7 Platinum 5000Various Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 
06/29/2017Agony BalmHart & Soul Herbal, LLCn/ahartandsoulherbal.comNew DrugsOnline Advisory LetterDrugs 
06/29/2017Auburn OilHart & Soul Herbal, LLCn/ahartandsoulherbal.comNew DrugsOnline Advisory LetterDrugs 
06/29/2017Rose of Sharon Salt/Olive SoapHart & Soul Herbal, LLCn/ahartandsoulherbal.comNew DrugsOnline Advisory LetterDrugs 
06/29/2017Mudd BombsHart & Soul Herbal, LLCn/ahartandsoulherbal.comNew DrugsOnline Advisory LetterDrugs 
06/29/2017Harmony Castile SoapHart & Soul Herbal, LLCn/ahartandsoulherbal.comNew DrugsOnline Advisory LetterDrugs 
06/29/2017Rouse OilHart & Soul Herbal, LLCn/ahartandsoulherbal.comNew DrugsOnline Advisory LetterDrugs 
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08/06/2015LiDa DaiDaiHuaBlue Square Market Inc.North Huntingdon, PAcalcompnutriton.comUndeclared sibutramine and phenolphthaleinRecallDrugs 
08/06/2015Achieving ZeroVarious Distributorsn/aamazon.comUndeclared sibutraminePublic NotificationDrugs 
07/02/2015Akttive CapsulesLife & More, L.L.C.Miami, FLakttive.comUndeclared sibutramine, desmethylsibutramine, and phenolphthaleinPublic NotificationDrugsRecall
07/02/2015Zero XtremeFat Burners Zonen/azeroxtremeusa.comUndeclared sibutramine and desmethylsibutraminePublic NotificationDrugsRecall
06/12/2015PyrolaG&C Natural Nutrition, Inc,Fullerton, CAN/AUndeclared diclofenacRecallDrugs 
06/05/2015Pyrola Advanced Joint FormulaVarious Distributorsn/aamazon.comUndeclared diclofenacPublic NotificationDrugs 
06/05/2014Zhen Gong FuVarious Distributorsn/an/aUndeclared sildenafilPublic NotificationDrugs 
06/03/2015Smart LipoSmartLipo365 and Centro Naturista2915 East Division Street, Suite 523, Arlington, TX76011smartlipo365.comUndeclared sibutramine, desmethylsibutramine, and phenolphthaleinRecallDrugs

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 HardVarious 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 sildenafilRecallDrugs 
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 NotificationDrugsRecall
12/19/2014B-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 ShipmentsUndeclaredPublic 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 sildenafilWarning 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 sildenafilWarning LetterDrugs 
09/26/2014African Black AntNova Products, Inc.5 Mount Pleasant Road, Aston, PA 19014n/aUndeclared sildenafilWarning 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 BurnerNew Life Nutritional Centern/an/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 
03/26/2014Maxi GoldNew Life Nutritional Centern/an/aUndeclared sibutramine and/or phenophthaleinRecallDrugs 
03/26/2014EsmeraldaNew 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 Letter
01/28/2014JINQIANGBUDOR 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 Letter
01/21/2014Magic SlimSlim Beauty USA503 E. 23rd St. Kearney, NE 68847slimbeautyusa.comUndeclared sibutraminePublic NotificationDrugsWarning Letter
01/15/2014Pro 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 NotificationDrugsRecall
12/23/2013Mass 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 sibutraminePublic NotificationDrugs 
12/19/2013Dr. Ming's Chinese CapsuleVarious Distributorsn/aslimbeautyusa.comUndeclared sibutraminePublic NotificationDrugsWarning Letter
12/19/2013Sliming 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-BoostTendexLos Angeles, CAn/aUndeclared tadalafilRecallDrugs 
11/19/2013NatuRECTTendexLos Angeles, CAn/aUndeclared tadalafilRecallDrugs 
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 SolutionsVarious Distributorsn/an/aUndeclared sibutraminePublic NotificationDrugs 
10/10/2013Bella Vi Insane Amp’dVarious 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 
09/24/2013PHUKHaute Health, LLCWilliamstown, NJvirilispro.comUndeclared sildenafilRecallDrugs 
09/24/2013ProliftaHaute 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 chlorpormazineRecallDrugs 
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 
05/07/2013SexVoltzBeaMonstar ProductsQueen Creek, AZn/aUndeclared tadalafilRecallDrugsExpanded Recall
05/07/2013VelextraBeaMonstar ProductsQueen Creek, AZn/aUndeclared tadalafilRecallDrugs 
05/07/2013AmerectBeaMonstar 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 tadalafilRecallDrugs 
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 Letter
04/25/2013Sex 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 Update
12/19/2012Slimdia RevolutionP&J Tradingn/apinkfatty.comUndeclared sibutramineRecallDrugsPublic Notification
12/17/2012Libigrow 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 Update
05/25/2012Mojo 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.bizUndeclaredPublic NotificationDrugs 
04/20/2012ZenMaxxEnhance NutraceuticalMalaysiazenmaxx.comUndeclared aminotadalafilPublic NotificationDrugsWarning Letter
04/20/2012Instant Hard RodEnhance NutraceuticalMalaysiainstanthardrod.comUndeclared aminotadalafilPublic NotificationDrugsWarning Letter
04/20/2012RigiRx PlusEnhance NutraceuticalMalaysiarigirxplus.comUndeclared aminotadalafilPublic NotificationDrugsWarning Letter
04/05/2012African 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