A nationwide recall has been executed for RegenArouse, Lot Number 130100, by Regeneca Inc. FDA lab analysis has confirmed the presence of tadalafil, making this product an unapproved drug. Tadalafil is an FDA-approved drug used as a treatment for erectile dysfunction (ED).

Use of this product may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Regeneca, Inc. distributed RegenArouse via sales made over the internet to consumers in the U.S. and Puerto Rico between November 29, 2011 and February 10, 2012. RegenArouse, Lot Number 130100, is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079.

For more information, visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291577.htm.