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Alerts

Dietary Supplements for Erectile Dysfunction - Dangerous Ingredients
- UPDATED

November 18, 2009

The dietary supplements Actra-Rx, Aspire36, Aspire Lite, Axcil, Blue Steel, Desirin, Encore Tabs, Energy Max, Herbal Disiac, Hero, Libidus, LibieXtreme, Libimax, Libimax X, Libipower Plus, Liviro3, Nasutra, Neophase, Powermania, RockHard Weekend, Rhino V Max, Rize 2 The Occasion, Rose 4 Her Capsules, Shangai (various products), Stamina-Rx, Steam, Stiff Nights, True Man, V. Max, Viapro, Vigor-25, Viril-Ity-Power, Xiadafil VIP, Y-4ever, Zencore, Zimaxx, or 4EVERON may contain analogs of sildenafil, tadalafil, or vardenafil. The dietary supplement Zencore Plus may contain benzamidenafil, another phosphodiesterase-5 (PDE-5) inhibitor. These agents are marketed on web sites as natural products for erectile dysfunction or sexual enhancement. The labeling for these products does not mention these ingredients and the FDA considers these products to be illegal drugs.

Over the last 2 years, the following specific products have been recalled in response to FDA analyses:

• Cosmos Trading, Inc. recalled Rhino V Max following an FDA analysis which revealed aminotadalafil in Rhino V Max products. Aminotadalafil is an analogue of tadalafil, an FDA-approved drug.
• Bodee LLC, Inc voluntarily recalled Encore Tabs following an FDA analysis that found one lot contained aminotadalafil.
• Another aminotadalafil containing supplement, branded V. Max by Baradon SF, has also been recalled.
• Ebek, Inc. voluntarily recalled Liviro3 following an FDA analysis which revealed that Liviro3 contained tadalafil.
• Bodee LLC, Inc voluntarily recalled Zencore following an FDA analysis which found that one lot contained aminotadalafil and another lot contained sildenafil and the sildenafil analogs, sulfosildenafil and sulfohomosildenafil.
• TWC GLobal LLC, Inc voluntarily recalled Axcil and Desirin following an FDA analysis which found that one lot contained sildenafil, sulfosildenafil, and sulfohomosildenafil.
• Palo Alto Labs voluntarily recalled Aspire36 and Aspire Lite after an FDA analysis showed that samples contained aildenafil and sulfoaildenafil (a sildenafil analog).
• International pharmaceuticals voluntarily recalled Viril-Ity-Power following an FDA analysis which revealed Viril-Ity-Power contained hydroxyhomosildenafil, an analog of sildenafil.
• Jack Distribution, LLC voluntary recalled certain lots of Rose 4 Her Capsules and Rize 2 The Occasion Capsules after an FDA-analysis showed they contain thiomethisosildenafil, an analog of sildenafil.
• EG Labs volunatarily recalled Viapro 375 mg capsules because one lot was found to contain thiomethisosildenafil, an analog of sildenafil.
• Bodee LLC recalled Zencore Plus because it was found to contain benzamidenafil, a recently discovered PDE5 inhibitor.
• Nature & Health Co. voluntarily recalled Libimax following an FDA analysis which revealed that Libimax contained tadalafil.
• Hi-Tech Pharmaceuticals recalled Stamina-Rx because it contained benzamidenafil.
• Haloteco recalled Libipower Plus because it contained tadalafil.
• Nature & Health Co. recalled LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsules, and Herbal Disiac because they contain tadalafil, sulfoaidenafil, or aminotadalafil.
• Nutracoastal Trading LLC recalled Steam because the product contains sulfoaidenafil, an analog of sildenafil.
• Impulsaria LLC recalled Stiff Nights because the product contains sulfoaidenafil, an analog of sildenafil.
• RockHard Laboratories recalled RockHard Weekend because the product contains sulfoaidenafil, an analog of sildenafil. Specific lots recalled include the Blister Pack (lot T12 705 08 and T12 705 09), 3 count bottles (R417 0509) and 8 count bottles (T237-0509)

Additionally, FDA has warned consumers not to purchase the following products:

• Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also marketed as Shangai Chaojimengnan) products. These products originate from China and may contain sildenafil or an analog of sildenafil.
• Hero and Blue Steel products also contain sildenafil.
• Xiadafil VIP Tablets, branded by SEI Pharmaceuticals, contain hydroxyhomosildenafil, an analog of sildenafil.

Consumers are at risk due to these undeclared ingredients because they may interact with prescription drugs such as nitrates. The FDA is warning patients not to purchase or consume these products and report any adverse events via MedWatch (www.fda.gov/MedWatch/report.htm or 1-800-FDA-1088).

• FDA MedWatch alerts:
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153883.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153111.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153145.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153160.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152964.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153162.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153005.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153109.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153150.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm064960.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm074863.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm070058.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm070054.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm070020.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm070049.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127785.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm143820.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm168017.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171914.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172312.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174339.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189300.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191052.htm

• FDA News Releases:
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108690.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2007/ucm112089.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2007/ucm112130.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2007/ucm112127.htm
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109020.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2007/ucm112268.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2007/ucm112274.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2007/ucm112307.htm
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109049.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112386.htm
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116870.htm
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116901.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112448.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112475.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112465.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112472.htm
  http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm128422.htm
  http://www.fda.gov/Safety/Recalls/ucm143630.htm
  http://www.fda.gov/Safety/Recalls/ucm167139.htm
  http://www.fda.gov/Safety/Recalls/ucm171740.htm
  http://www.fda.gov/Safety/Recalls/ucm172264.htm
  http://www.fda.gov/Safety/Recalls/ucm174229.htm
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189295.htm
  http://www.fda.gov/Safety/Recalls/ucm191001.htm

Updated
November 18, 3009; November 6, 2009; July 29, 2009; July 16, 2009; July 15, 2009; June 22, 2009; April 29, 2009; March 20, 2009; July 31, 2008, July 3, 2008; May 30, 2008; March 26, 2008; March 5, 2008; November 27, 2007; September 24, 2007; September 7, 2007; May 11, 2007; March 21, 2007; January 26, 2007; July 18, 2006; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.