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U.S. Department of Health and Human Services

For Consumers

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Recalls - Health Fraud

The list below provides information gathered from press announcements and other public notices about certain recalls of health fraud* - related products regulated by FDA. For all FDA recalls, click here

 
 

2014

Brand NameDateProduct DescriptionReason/ProblemCompany
African Black Ant, Black Ant, XZen Gold, ZXen Platinum, XZen 1200, XZone Gold, and XZone 120003/27/2014Dietary SupplementsUnapproved drug; contains undeclared sildenafil or tadalafilNova Products, Inc.
Alli03/27/2014Alli Weight Loss ProductConcerns about authenticity of productGlaxoSmithKline (GSK) Consumer Healthcare
Bella Vi03/26/2014Dietary SupplementUnapproved drug; contains undeclared sibutramine, phenolphthalein or a combination of bothPure Edge Nutrition, LLC
Super Fat Burner, Maxi Gold, and Esmeralda03/25/2014Dietary SupplementsUnapproved drug; contains undeclared sibutramine, phenolphthalein or a combination of bothNew Life Nutritional Center
Pain Free By Nature03/12/2014Reumofan Plus TabletsUnapproved drug; contains undeclared methocarbamol and diclofenacPain Free By Nature
Slimeasy, Fruta Bio, Magic Slim, Meizi Evolution and more02/04/2014Dietary SupplementsUnapproved drugs; contains undeclared phenolphthalein, sibutramine, or a combination of bothMyNicKnaxs, LLC.
Reduce Weight Fruta Planta02/04/2014Dietary SupplementUnapproved drug; contains undeclared phenolphthaleinMyNicKnaxs, LLC.
Young You01/30/2014Dietary SupplementContains 1,3 dimethylamylamine (DMAA)Young You Corporation
Pro ArthMax01/13/2014Dietary SupplementUnapproved drug; contains undeclared Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and IndomethacinHuman Science Foundation
Boost Ultra, XZone Gold & more01/09/2014Dietary SupplementUnapproved drug; contains undeclared Sildenafil and/or TadalafilMidwest Wholesale

 

 

2013

Brand NameDateProduct DescriptionReason/ProblemCompany
Burn 712/23/2013Dietary SupplementUnapproved drug; contains undeclared SibutramineDeseo Rebajar Inc.
Hydravax11/29/2013Dietary SupplementUnapproved drug; contains undeclared diureticIQ Formulations
Deseo Rebajar Inc.11/21/2013Dietary SupplementUnapproved drug; contains undeclared fluoxetineDeseo Rebajar Inc.
OxyElite Pro11/19/2013Dietary SupplementProducts are associated with serious liver damage or acute liver failureUSPlabs LLC
Tendex11/19/2013Dietary SupplementUnapproved drug; contains undeclared tadalafilTendex
RezzRx11/18/2013Dietary SupplementUnapproved drug; contains undeclared hydroxylthiohomosildenafil and aminotadalafilFossil Fuel Products, LLC
Jobbers Wholesale11/16/2013Dietary SupplementUnapproved drug; contains undeclared desmethylcarbondenafil and dapoxetine Jobbers Wholesale
VitaliKOR11/13/2013Dietary SupplementUnapproved drug; contains undeclared Vardenafil and TadalafilVitality Research Labs, LLC
OxyElite Pro11/09/2013Dietary SupplementProducts are associated with serious liver damage or acute liver failureUSPlabs LLC
Slim Fortune, Lidiy, Slim Expert10/07/2013Dietary SupplementUnapproved drug; contains undeclared SibutramineB @ B Trade, Inc.
Virilis Pro, PHUK, Prolifta09/24/2013Dietary SupplementUnapproved drug; contains undeclared SildenafilHaute Health, LLC
Ge Pharma Creafuse09/12/2013Dietary SupplementContains 1,3 dimethylamylamine (DMAA)Ge Pharma, LLC
Pro Power Max, 72HP, Evil Root08/27/2013Dietary SupplementUnapproved drug; contains undeclared SildenafilHardmenstore.com
Esbelder men, Esbelder fem, and Esbelder siloutte Vitamin Supplements08/16/2013Dietary SupplementUnapproved drug; contains undeclared Sibutramine, N-Desmethylsibutramine, and N-di-DesmethylsibutramineHerbal Give Care LLC
Jack Rabbit08/12/2013Dietary SupplementUnapproved drug; contains undeclared Sildenafil and TadalafilJack Rabbit Inc.
Tranquility08/07/2013Dietary SupplementUnapproved drug; contains undeclared Doxepin and ChlorpromazineHealth and Beyond LLC
Bethel08/05/2013Weight Loss PillsUnapproved drug; contains undeclared Sibutramine and PhenolphthaleinBethel Nutritional Consulting, Inc.
Esbelin siloutte te and Esbelin siloutte Vitamin Supplement07/19/2013Dietary SupplementUnapproved drug; contains undeclared Sibutramine, N-Desmethylsibutramine, and N-di-DesmethylsibutramineHerbal Give Care LLC
Volcano07/18/2013Dietary SupplementUnapproved drug; contains undeclared Desmethyl Carbodenafil, Dimethylsildenafil, and DapoxetineVolcano Company
Silver Sword, Clalis07/05/2013Dietary SupplementsUnapproved drug; contains undeclared SildenafilHardmenstore.com
Oxyphen XR, Phentalene, Phen FX, Red Vipers06/20/2013Dietary SupplementsProducts contain 1,3 dimethylamylamine (DMAA)Beta Labs, LTD
Bethel06/11/2013Dietary SupplementUnapproved drug; contains undeclared Sibutramine and PhenolphthaleinBethel Nutritional Consulting, Inc.
SexVoltz, Velextra, Amerect05/10/2013Dietary SupplementUnapproved drug; contains undeclared TadalafilBeaMonstar Products
Lightning Rod05/07/2013Dietary SupplementUnapproved drug; contains an undeclared analog of SildenafilChang Kwung, Inc.
Vicerex, Black Ant05/01/2013Dietary SupplementUnapproved drugs; contains undeclared Tadalafil and SildenafilAmerican Lifestyle
Affirm XL04/10/2013Dietary SupplementUnapproved drug; contains an undeclared analog of SildenafilAffirm XL
ROCK-IT-MAN04/02/2013Dietary SupplementUnapproved drug; contains undeclared hydroxythiohomosildenafil, analog of SildenafilConsumer Concepts, Inc.
Night Bullet03/11/2013Dietary SupplementUnapproved drug; contains undeclared sulfohydroxyhomosildenafil and aminotadalafil, analogs of Sildenafil and TadalafilGreen Planet, Inc.
Maxiloss Weight Advanced02/21/2013Dietary SupplementUnapproved drug; contains undeclared SibutramineOlaax Corporation
Reumofan Plus02/15/2013TabletsTablets contain undeclared active pharmaceutical ingredients: methocarbamol, dexamethasone, and diclofenacReumofan Plus USA, LLC and Reumofan USA, LLC
Super Power01/24/2013Dietary SupplementUnapproved drug; contains undeclared SildenafilD&S Herbals, LLC, d/b/a Freedom Trading

 

 

2012

Brand NameDateProduct DescriptionReason/ProblemCompany
Slimdia Revolution12/21/2012Dietary SupplementUnapproved drug; contains undeclared SibutramineP&J TRADING
Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, and Casanova12/17/2012Dietary SupplementUnapproved drugs; contains undeclared sulfoaildenafil and thioaildenafil, analogs of Sildenafilanalogs of SildenafilPerformance Plus Marketing, Inc.
Classic Zi Xiu Tang Bee Pollen and Ultimate Formula10/24/2012Dietary SupplementUnapproved drugs; contains undeclared SibutramineZi Xiu Tang Success, LLC
ACTRA-Sx 50009/12/2012Dietary SupplementUnapproved drug; contains undeclared SildenafilBody Basics, Inc.
Brand New Energy08/30/2012EphBurn 25 dietary supplementUndeclared ephedrine alkaloidsBrand New Energy
Samantha Lynn Inc.08/24/2012Reumofan Plus TabletsUndeclared drug ingredients methocarbamol, dexamethasone and diclofenacSamantha Lynn Inc.
X-ROCK 3 Day Pill and Z-ROCK07/20/2012Supplement for Erectile Dysfunction (ED)Unapproved drug; contains undeclared SildenafilCRM Laboratories
V Maxx05/26/2012Supplement for Erectile Dysfunction (ED)Unapproved drug; contains undeclared sulfoaildenafil, analog of SildenafilThe Menz Club, LLC
Firminite, Extra Strength Instant Hot Rod, Libidron05/18/2012Supplement for Erectile Dysfunction (ED)Unapproved drug; contains undeclared TadalafilWest Coast Nutritionals, Ltd.
X-ROCK04/19/2012Male Sexual Performance SupplementUnapproved drug; contains undeclared Sildenafil and hydroxythiohomosildenafilXROCK Industries
RegenErect02/24/2012Intimacy Enhancement CapsulesUnapproved drug; contains undeclared TadalafilRegeneca, Inc.
Healthy People Co.02/22/2012Dietary SupplementsUnapproved drug; contains undeclared Sibutramine and TadalafilHealthy People Co.
RegenArouse02/10/2012Intimacy Enhancement CapsuleUnapproved drug; contains undeclared TadalafilRegeneca, Inc.
Healthy People Co.02/03/2012Dietary SupplementsUnapproved drug; contains undeclared Sibutramine and TadalafilHealthy People Co.

 

 

2011

Brand NameDateProduct DescriptionReason/ProblemCompany
Virility Max11/10/2011Virility Max Dietary SupplementUnapproved drug; contains undeclared sulfoaildenafil, analog of SildenafilKeime, Incorporated
Uprizing 2.010/03/2011Testosterone BoosterUnapproved drug; contains undeclared SuperdrolSuperior Metabolic Technologies, Inc.
Slim Forte, Meizitang Botanical09/02/2011Slimming Capsules and CoffeeUnapproved drug; contains undeclared sibutramineIntercharm, Inc.
Qualiherb07/28/2011Dietary SupplementUndeclared Ephedrine AlkaloidsFinemost Corporation dba Qualiherb
Via Xtreme07/13/2011Dietary SupplementUnapproved drug; contains undeclared sulfoaildenafil methanesulfonate, sulfoaildenafil, and dimethylsildenafil, analogs of SildenafilGlobal Wellness LLC
Via Xtreme06/06/2011Dietary SupplementUnapproved drug; contains undeclared sulfoaildenafil methanesulfonate, sulfosildenafil, and dimethylsildenafil, analogs of SildenafilGlobal Wellness LLC
Slim Xtreme Herbal Slimming Capsule05/24/2011Dietary SupplementUnapproved drug; contains undeclared sibutramineGlobal All Wellness, LLC
Pentrexyl Forte Natural05/19/2011Dietary SupplementLabeling may confuse consumers to believe that product is an antibiotic drugPhoenix Import & Distribution LLC
Pentrexyl Forte Natural05/12/2011Dietary SupplementLabeling may confuse consumers to believe that product is an antibiotic drugPhoenix Import & Distribution LLC
M. Vermex, Pentreximil, Terramocina, more05/09/2011Dietary SupplementsMay be labeled as antibiotic drugsMulti-Mex Distributor, Inc.
Regenerect04/28/2011Dietary SupplementUnapproved drug; contains undeclared sulfoaildenafil, analog of SildenafilEthos Environmental, Inc.
THE BEST03/28/2011THE BEST Enhancement Supplement  Unapproved drug; contains undeclared sulfoaildenafil, analog of sildenafilAVNS, Inc.
X-Hero, Male Enhancer03/25/2011X-Hero and Male Enhancer Dietary Supplements  Unapproved drug; contains undeclared sulfoaildenafil, analog of Sildenafil, and TadalafilUSA Far Ocean Group, Inc.
U-Prosta03/22/2011U-Prosta Natural support for prostate health  Unapproved drug; contains undeclared Terazosin HydrochlorideUSA Far Ocean Group Inc.
Celerite03/15/2011Dietary Supplement Tea Unapproved drug; contains undeclared Sibutramine Shaping Beauty, Inc.
EXTENZE02/22/2011EXTENZE nutritional supplement tabletsUnapproved drug; containes undeclared Sibutramine, Tadalafil, and SildenafilBiotab Nutraceuticals, Inc.
Svelte 3002/09/2011Svelte 30 Herb Supplement, orange & gray capsules Unapproved drug; contains undeclared Sibutramine Svelte 30 Nutritional Consultants 
Celerite 01/24/2011Celerite Slimming Capsules Unapproved drug; contains undeclared sSbutramine Shaping Beauty, Inc.
Stud, Nite Rider 01/18/2011Dietary SupplementUnapproved drug; contains undeclared SildenafilKanec USA

 

 

2010

Brand Name DateProduct DescriptionReason/ProblemCompany
RockHard Extreme, Passion Coffee 12/30/2010Rock Hard Extreme and Passion Coffee Dietary Supplements Unapproved drug; contains undeclared analog of SildenafilDrive Total Energy 
Fruta Planta12/30/2010Fruta Planta CapsuleUnapproved drug; contains undeclared sibutramine PRock Marketing LLC
RockHard Weekend, Pandora12/22/2010RockHard Weekend and Pandora dietary supplements Unapproved drug; contains undeclared analog of SildenafilRockHard Laboratories 
Aspire One, Sex Enhancer, Staminil12/14/2010Dietary SupplementUnapproved drug; contains undeclared sulfoaildenafil, analog of SildenafilAtlas Operations, Inc.
Duro Extend10/27/2010Duro Extend Capsules for MenUnapproved drug; contains undeclared sulfoaildenafil, analog of SildenafilIntelli Health Products
Novedex XT10/08/2010Novedex XTMay contain an Aromatase Inhibitor Gaspari Nutrition
Advanced Muscle Science09/16/2010Arom-X, Arom-X UTT, Arom-XL, 4-AD, and Decavol May contain an Aromatase Inhibitor Advanced Muscle Science 

Fizogen Precision Technologies

09/15/2010Off Cycle II Hardcore May contain an Aromatase Inhibitor Fizogen Precision Technologies
MasXtreme08/24/2010Dietary Supplement Capsules

Unapproved drug; contains undeclared  aminotadalafil, an analog of Tadalafil

Natural Wellness, Inc. 
Don Wands08/18/2010Dietary Supplemetn, Mr. Magic Male EnhancerUnapproved drug; contains undeclared sulfoaildenafil and hydroxythiosildenofil, analogs of SildenafilGlow Industries, Inc.
Slim-3008/18/2010Slim-30 Herb SupplementUnapproved drug; contains undeclared desmethyl sibutramine J & H Besta Corp. 
Novacare08/10/2010Dietary SupplementUnapproved drug; contains undeclared sulfoaildenafil, analog of Sildenafil Novacare LLC
Prolatis' 08/09/2010Dietary supplement Unapproved drug; contains undeclared sulfoaildenafil, analog of Sildenafil Prolatis’ 
Revivexxx Extra Strength 08/06/2010Dietary supplementUnapproved drug; contains undeclared TadalafilEZVille, Ltd.
Solo Slim08/06/2010Dietary SupplementUnapproved drug; contains undeclared Didesmethyl SibutramineEZVille, Ltd.
Ejaculoid XXTREME, Stimuloid II07/28/2010Dietary SupplementUnapproved drug; contains sulfoaildenafil, analog of SildenafilNutraloid Labs, Inc.
Joyful Slim07/22/2010Dietary SupplementUnapproved drug; contains undeclared Didesmethyl SibutramineJ & H Besta Corp.
Vialipro07/16/2010Dietary SupplementUnapproved drug; contains undeclared sulfoaildenafil, analog of Sildenafil Good Health, Inc.
Slim-30 Herb Supplement07/16/2010Dietary SupplementUnapproved drug; contains undeclared N-Desmethyl Sibutramine, and SibutramineJ & H Besta Corp. 
Magic Power Coffee06/25/2010Dietary SupplementUnapproved drug; contains undeclared hydroxythiohomosildenafil, analog of Sildenafil INZ Distributors Inc./Magic Power Coffee Inc. 
72 Hours (all strengths), Amour Again for Him, Arousin, more04/12/2010Dietary SupplementUnapproved drug; contains undeclared sulfoaildenafil, analog of SildenafilAtlas Operations, Inc.
Stud Capsule04/02/2010Dietary SupplementUnapproved drug; contains undeclared SildenafilKanec USA Inc.
MasXtreme03/30/2010Dietary SupplementUnapproved drug; contains undeclared aildenafil, analog of Sildenafil, and PhentolamineNatural Wellness, Inc.
Advanced Muscle, Anabolic Formulation, Anabolic Xtreme, more 01/15/2010Dietary SupplementsMay contain steroids: Superdrol, Madol, Tren, Androstenedione, and/or TurinabolMuscleMaster.com, Inc. 

 

 

2009

Brand Name DateProduct DescriptionReason/ProblemCompany
Aspire One, Sex Enhancer, Staminil, more12/11/2009Dietary SupplementUnapproved drug; contains undeclared sulfoaildenafil, analog of SildenafilAtlas Operations, Inc.
Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, Ripped Tabs11/12/200Dietary SupplementMay contain steroids: Superdrol, Madol, Androstenedione, and/or TurinabolIDS Sports
Pai You Guo11/12/2009Dietary SupplementUnapproved drug; contains undeclared Sibutramine, PhenolphthaleinGMP Herbal Products, Inc.
RockHard Weekend11/09/2009Dietary SupplementUnapproved drug; contains undeclared sulfoaildenfil, analog of SildenafilRockHard Laboratories
Superdrol, Madol, Tren, Androstenedione, Turinabol11/03/2009Dietary SupplementMay contain steroids: Superdrol, Madol, Tren, Androstenedione, and/or TurinabolBodybuilding.com
STEAM08/21/2009Dietary SupplementUnapproved drug; contains undeclared TadalafilNutracoastal Trading LLC
STEAM07/28/2009Dietary SupplementUnapproved drug; contains undeclared SildenafilNutracoastal Trading LLC
S-DROL07/28/2009Dietary SupplementUnapproved drug; contains undeclared DesoxymethyltestosteroneNutracoastal Trading LLC
Slimbionic, One Weight Loss Pill, SlimDemand, Botanical Weight Loss07/15/2009Dietary SupplementUnapproved drug; contains undeclared SibutramineYoung You Corporation
LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid, Herbal Disiac, more07/15/2009Dietary SupplementUnapproved drug; contains undeclared sulfoaidenafil, sulfoaidenafil, analogs of Sildenafil, aminotadafil, analog of Tadalafil, and TadalafilNature & Health Co.
Libipower Plus07/13/2009Dietary SupplementUnapproved drug; contains undeclared TadalalafilHaloteco
Stamina-Rx06/15/2009Dietary SupplementUnapproved drug; contains undeclared Benzamidenafil, analog of SildenafilHi-Tech Pharmaceuticals
Hydroxycut05/07/2009Dietary SupplementAdverse reaction Iovate Health Sciences U.S.A., Inc.
Hydroxycut05/01/2009Dietary SupplementAdverse reaction Iovate Health Sciences U.S.A., Inc.
Hydroxycut05/01/2009Dietary SupplementAdverse reaction, risk of liver injuryIovate Health Sciences U.S.A., Inc.
Libimax04/27/2009Dietary SupplementUnapproved drug; contains undeclared TadalafilNature & Health Co.
ProSlim Plus, 3 DAYS fit, EIGHT FACTOR DIET, 24hours Diet, more04/20/2009Dietary SupplementUnapproved drug; contains undeclared SibutramineUniversal ABC Beauty Supply International, Inc.
Zencore Plus03/11/2009Dietary SupplementUnapproved drug; contains undeclared benzamidenafil, a newly discovered PDE5 inhibitor similar pharmacological properties as Sildenafil, Tadalafil, and VardenafilBodee LLC

 

 

2008

Brand Name DateProduct DescriptionReason/ProblemCompany Name
Starcaps12/08/2008Dietary SupplementUnapproved drug; contains undeclared BumetanideBalanced Health Products, Inc.
Starcaps11/26/2008Dietary SupplementUnapproved drug; contains undeclared SibutramineBalanced Health Products, Inc.
Zhen De Shou Fat Loss Capsules11/23/2008Dietary SupplementUnapproved drug; contains undeclared SibutramineFashion Sanctuary
Rize 2 The Occasion, Rose 4 Her07/28/2008Dietary SupplementUnapproved drug; contains undeclared thiomethisosildenafil, analog of SildenafilJack Distribution, LLC
Viapro07/23/2008Dietary SupplementUnapproved drug; contains undeclared thiomethisosildenafil, analog of SildenafilEG Labs
Rize 2 The Occasion, Rose 4 Her07/01/2008Dietary SupplementUnapproved drug; contains thiomethisosildenafil, analog of SildenafilJack Distribution, LLC
Viril-Ity-Power (VIP) Tabs05/29/2008Dietary SupplementUnapproved drug; contains hydroxyhomosildenafil, analog of SildenafilInternational Pharmaceuticals, Ltd.
Wu Yao Shun Qi San, Qing Bi Tang (Nasal Cleanser), more04/10/2008Dietary SupplementUnapproved drug; contains undeclared ephedra, aristolochic acid, or human placentaHerbal Science International, Inc.
Maxidus03/31/2008Dietary SupplementUnapproved drug; contains undeclared SildenafilKG Enterprises LLC
Aspire36, Aspire Lite02/28/2008Dietary SupplementUnapproved drug; contains undeclared aildenafil, sulfoaildenafil, analogs of sildenafilPalo Alto Labs

 

 

2007

 Brand NameDateProduct DescriptionReason/ProblemCompany Name
Encore Tabs11/21/2007Dietary SupplementUnapproved drug, contains undeclared aminotadalafil, analog of TadalafilBodee LLC
True Man's Sexual Energy Nutriment Men's Formula, Energy Max11/16/2007Dietary SupplementUnapproved drug, contains undeclared analog similar to Tadalafil, Vardenafil, and SildenafilAmerica True Man Health Incorporated
Axcil, Desirin09/12/2007Dietary SupplementUnapproved drug, contains undeclared sulfosildenafil, sulfohomosildenafil, analogs of Sildenafil, and SildenafilTWC Global LLC
Zencore Tabs08/31/2007Dietary SupplementUnapproved drug, contains undeclared aminotadalafil, analog of Tadalafil, sulfosildenafil, sulfohomosildenafil, analogs of Sildenafil, and SildenafilBodee LLC
METABOSLIM Apple Cider Vinegar08/17/2007Dietary SupplementUnapproved drug, contains undeclared SibutramineConfidence, Inc.
Long Weekend06/14/2007Dietary SupplementUnapproved drug, contains undeclared TadalafilConfidence, Inc.
H S Joy of Love04/17/2007Dietary SupplementUnapproved drug, contains undeclared piperadino vardenafil, analog of VardenafilJen-On Herbal Science International, Inc.
Rhino Max (Rhino V Max)03/16/2007Dietary SupplementUnapproved drug, contains undeclared aminotadalafil, analog of TadalafilCosmos Trading, Inc.
Liviro301/29/2007Dietary SupplementUnapproved drug, contains undeclared TadalafilEbek, Inc.
Liviro301/19/2007Dietary SupplementUnapproved drug, contains undeclared TadalafilEbek, Inc.

 

 *The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.