'Male enhancement' supplement recalled due to undeclared erectile dysfunction drug

NEW YORK (FOX 5 NY) - Almost everything about this story sounds like a joke but we assure you—it isn't. And it is important because it is about an undeclared drug. A company called Stiff Boy LLC (again—we're not joking) is voluntarily recalling all lots of a capsule it sells called The Beast, a dietary supplement marketed for "male enhancement."

So why is The Beast being recalled? Because FDA testing showed the supplement is tainted by the drug sildenafil, which treats erectile dysfunction and is the active ingredient in the brand-name medication Viagra.

"We feel that The Beast will save relationships in the bedrooms all across the nation no matter what age," Stiff Boy LLC claims on its product website, which is youcanbeabeast.com. "You will see and feel a difference the first day you try our product. Your wife, girlfriend or partner will ask you what did you take to make The Beast in you come out of the cage."

But the claims that a company makes about a dietary supplement aren't subject to FDA evaluation. So if a supplement actually contains a drug, even one that (in this case) could make the pill work as marketed, the FDA considers it an unapproved drug that could pose safety issues.

Sildenafil is in a class of drugs called phosphodiesterase (PDE-5) inhibitors, which can adversely interact with drugs containing nitrates.

"Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected," Stiff Boy LLC said in its recall announcement.

However, the company said it had not received any reports of consumers having "adverse events" related to this recall as of May 6.

Stiff Boy LLC is instructing consumers who have The Beast to "stop using it immediately and return to the place of purchase,"

If you have any questions, you can contact Stiff Boy LLC at either 914-281-4059 or info@youcanbeabeast.com.