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Alerts

Dietary Supplements for Erectile Dysfunction - Dangerous Ingredients
- UPDATED

March 29, 2011

The dietary supplements 72 Hours, APL, Actra-Rx, Amour for him, Arousin, Aspire36, Aspire Lite, Aspire One, Axcil, Aziffa, Blue Steel, Clyamax, Depth Charge, Desirin, Ejaculoid Xxtreme, Encore Tabs, Energy Max, Enhancement, Erex, Erexa, Erexxx, Erousa, Eyeful, Ezerex, Finally On Demand, Hard Drive, Herbal Disiac, Hero, Libidinal, Libidus, LibieXtreme, Libimax, Libimax X, Libiplus, Libipower Plus, Liviro3, Love Fuel, Love Fuel 2, Magic Power Coffee, Man Up Now, MasXtreme, Maxyte, Male Enhancer, Mojo, Monster Excyte, Mr. Magic Male Enhancer, Nasutra, Neophase, Pandora, Powermania, Prolatis, Rainbow Rocket, Red Hot Sex, Red Magic, Revivexxx Extra Strength, Rockhard, RockHard Weekend, Rhino V Max, Rize 2 The Occasion, OMG, OMG45, Rose 4 Her Capsules, Sex Enhancer, Sexual Surge, Size Matters, Shangai (various products), Stamina-Rx, Steam, Staminil, Stiff Nights, Stimuloid II, Straight Up, Stud Capsule for Men, Tacktol, Topviril, True Man, V. Max, Vaxitrol, Verect, Vialipro, Viapro, Vierect, Vigor-25, Viril-Ity-Power, Whatzup, WOW, X-Hero, Xiadafil VIP, Xiatrex, Xtremexcite, Xytamax, Y-4ever, Zencore, Zenerect, Zilex (with Golden Spear), Zimaxx, Zotrex, or 4EVERON may contain analogs of sildenafil, tadalafil, or vardenafil. The dietary supplement Zencore Plus may contain benzamidenafil, another phosphodiesterase-5 (PDE-5) inhibitor. MasXtreme may contain phentolamine in addition to a PDE-5 analog. 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 past few 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). Additionall, RockHard Weekend in blister packs and bottles of 3 and 8 count (lot numbers 100159 and 100260) have been recalled because tests found they contain an analogue of sildenafil.
• Atlas Operations, Inc. recalled several different brand name products because samples tested by FDA contained sulfoaildenafil, a sildenafil analog. The affected products were from the following lots: 494, 520, 520A, 520B, 520C, 521, 705, 706, 779, and 807.
• Natural Wellness, Inc. recalled MasXtreme, lot 911035 because samples tested by FDA contained aildenafil, a sildenafil analog, and phentolamine, an antihypertensive medication.
• Kanex USA recalled Stud Capsule for Men, lot 060607-01/060108-01 (expiry 6/2013) because samples tested by FDA contained sildenafil.
• Good Health, Inc. recalled multiple lot numbers of Vialipro capsules after samples tested by FDA contained sulfoaildenafil, a sildenafil analog.
• Nutraloid Labs, Inc. recalled multiple lot numbers of Ejaculoid Xxtreme and Stimuloid II after samples tested by FDA contained sulfoaildenafil, a sildenafil analog.
• EZVille Ltd. Recalled Revivexxx Extra Strength because samples tested by FDA contained tadalafil.
• Novacare LLC recalled lots of the following products manufactured or distributed before June 17, 2010: Aziffa, Erex, Eyeful, Hard Drive, Libidinal, Maxyte, Mojo, Monster Excyte, Prolatis, Red Magic, OMG, OMG45, Size Matters, Stiff Nights, Straight Up, Verect, WOW, Xiatrex, Xytamax, Zilex (with Golden Spear), and Zotrex. FDA notified Novacare LLC that these products appear to contain sulfoaildenafil, a sildenafil analog.
• Glow Industries, Inc. conducted a voluntary recall because FDA lab analysis found that Mr. Magic Male Enhancer contains hydroxythiohomosildenafil and sulfoaildenafil which are analogues of sildenafil. These active ingredients are not listed on the product label.
• Pandora in blister packs (lot number 100378) has been recalled because tests found it contains an analogue of sildenafil.
• USA Far Ocean Group recalled X-Hero because it contained sulfosildenafil, a sildenafil analog, and Male Enhancer because it contained tadalafil.

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.
• Magic Power Coffee contains hydroxythiohomosildenafil, an analog of sildenafil. This product is being distributed by various distributors over the Internet.
• Man Up Now capsules, distributed by Synergy Distribution LLC over the Internet, may contain sulfoaildenafil, 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
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm194091.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm206791.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm207630.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216355.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219580.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220650.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221687.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222052.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222327.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm223837.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234460.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238041.htm
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248814.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
  http://www.fda.gov/Safety/Recalls/ucm194074.htm
  http://www.fda.gov/Safety/Recalls/ucm206759.htm
  http://www.fda.gov/Safety/Recalls/ucm207479.htm
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216335.htm
  http://www.fda.gov/Safety/Recalls/ucm220601.htm
  http://www.fda.gov/Safety/Recalls/ucm222315.htm
  http://www.fda.gov/Safety/Recalls/ucm223082.htm
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234408.htm
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm236538.htm
  http://www.fda.gov/Safety/Recalls/ucm248718.htm

Updated
March 29, 2011; December 23, 2010; December 13, 2010; November 22, 2010; August 24, 2010; August 13, 2010; August 12, 2010; August 9, 2010; July 30, 2010; July 20, 2010; June 21, 2010; April 8, 2010; March 31, 2010; December 16, 2009; 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 2010, Drug Information Service, University of Utah, Salt Lake City, UT.