According to the FDA, RegenArouse (Lot 130100) contains tadalafil (Cialis), an FDA-approved drug used as treatment for male erectile dysfunction, making this product an unapproved new drug.

Here’s what we know.

  • Regeneca, Inc. is recalling this product.
  • RegenArouse is a pink capsule sold individually in foil packets.
  • The product in question has an expiration date of 12/5/2013 and a UPC code of 816860010079.

The bottom line?
RegenArouse 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.

FDA advises consumers with diabetes, high blood pressure, high cholesterol, or heart disease who are treated with nitrates should avoid this product.

2/13/12 19:56 JR

Hi, I’m JR

John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at, a complementary and alternative medicine website.