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2017 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.

Date Brand Name Product Description Reason/Problem Company Name
12/13/2017 Marmex Corp Marketed as a dietary supplement Unapproved new drug; contains undeclared sildenafil Marmex Corp
11/30/2017 Bull, Chao Jimengnan   Marketed as a dietary supplement Unapproved new drug; contains undeclared sildenafil Nutra Labs Inc.
10/05/2017 A1 Marketed as a dietary supplement Unapproved new drug; contains undeclared sibutramine, phenolphthalein and N-Desmethyl sibutramine Kiriko, LLC
10/04/2017 Rhino 7, Papa Zen, Fifty Shades, and Grand X Marketed as a dietary supplement Unapproved new drug; contains underclared sildenafil, tadalafil, and/or Desmethyl Carbodenafil Gadget Island, Inc. dba Gear Isle
09/20/2017 Natures Supplement, Inc.   Marketed as a dietary supplement Unapproved new drug; contains underclared sildenafil Natures Supplement, Inc.
09/20/2017 Rhino 7, Papa Zen, Fifty Shades, and Grand X   Marketed as a dietary supplement Unapproved new drug; contains underclared sildenafil, tadalafil, and/or Desmethyl Carbodenafil Gadget Island, Inc. dba Gear Isle
08/01/2017 AMPT Marketed as a dietary supplement Unapproved new drug; contains undeclared sildenafil and tadalafil; also contains undeclared milk The AMPT Life, LLC
07/31/2017 Man of Steel Marketed as a dietary supplement Unapproved new drug; contains undeclared sildenafil Man of Steel
07/24/2017 LaBri's Body Health Marketed as a dietary supplement Unapproved new drug; contains undeclared sibutramine EZ Weight Loss TX
07/21/2017 Super Panther 7K Marketed as a dietary supplement Unapproved new drug; contains undeclared sildenafil and tadalafil Ultra Shop Supplement
07/13/2017 New of Kopi Jantan Tradisional Marketed as a dietary supplement Unapproved new drug; contains undeclared sildenafil Bestherbs Coffee LLC
07/11/2017 Andropharm Marketed as a dietary supplement Contains derivatives of anabolic steroids Andropharm
06/29/2017 Ultra-Sten, D-Zine Marketed as a dietary supplement Contains anabolic steroids Hardcore Formulations
05/25/2017 Caverflo Marketed as natural herbal coffee Contains undeclared sildenafil and tadalafil, undeclared milk Caverflo.com
05/23/2017 The Green Herb Marketed as a dietary supplement Contains ephedra herb, an FDA banned ingredien MusclMasster LLC
05/19/2017 Tri-Ton Marketed as a dietary supplement Unapproved new drug; contains andarine and ostarine Dynamic Technical Formulations, LLC
05/05/2017 GEC Laxoplex  Marketed as a dietary supplement Contains anabolic steroids Genetic Edge Compounds
04/18/2017 Uproar, Cummor, Zrect, Monkey Business and others Marketed as a dietary supplement Unapproved new drug; contains undeclared tadalafil, sildenafil and their analogues, and flibanserin Organic Herbal Supply, Inc.
03/28/2017 LaBri’s Body Health Marketed as a dietary supplement Unapproved new drug; contains undeclared sibutramine Envy Me
03/09/2017 Regeneca Worldwide Various herbal and dietary supplements Not manufactured in compliance with cGMPs Regeneca Worldwide
03/07/2017 A&H Focal Inc. Marketed as a dietary supplement Unapproved new drug; contains undeclared PDE-5 Inhibitors (i.e. sildenafil, tadalafil, vardenafil, etc.) A&H Focal Inc.
02/16/2017 XtraHRD Marketed as a dietary supplement Unapproved new drug; contains undeclared tadalafil Organic Herbal Supply, Inc.
02/07/2017 Well Balance Marketed as a dietary supplement Product contains banned substance, Ephedra Herba Kingsway Trading 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.

 

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