FDA issues recall of male enhancement supplement

Feb. 14 (UPI) -- A California-based company is recalling male enhancement pills over concerns the gel capsules contain two unauthorized prescription medications, the U.S. Food and Drug Administration confirmed Tuesday.

The 2,000 mg capsule of PrimeZen Black 6000 sold by Volt Candy may contain traces of sildenafil and tadalafil, the FDA said in a statement.

"The presence of sildenafil, tadalafil in PrimeZen Black 6000 capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall," the administration said.

Classified as a food rather than a drug, the product is marketed and sold as a dietary supplement and thus subject to different FDA rules than prescription medication.

Sildenafil is sold under the brand name Viagra, while tadalafil is more commonly known as Cialis, and both are restricted to use under the supervision of a licensed healthcare professional.

The two prescription medications are used to treat male male erectile dysfunction and if mixed with other medications, could "interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening," according to the FDA warning.

Patients treating diabetes, high blood pressure, high cholesterol, or heart disease are routinely prescribed nitrates.

The recalled packages have an expiry date of August, 2025.

The FDA is continuing to warn companies that undisclosed prescription medications in products violate federal statutes.

Anyone in possession of the products is encouraged to return them to the company, based in Pomona, Calif.

In a similar case, the FDA confirmed in August it sent letters in the previous month to four companies, warning them their honey products contained sildenafil and tadalafil, the same two active prescription ingredients.