Male enhancement pills are being recalled over concerns that the gel capsules contain two unauthorized prescription medications, the U.S. Food and Drug Administration announced Tuesday.
The 2,000 mg capsule of PrimeZen Black 6000 sold by Californian-based Volt Candy may contain traces of sildenafil and tadalafil, the FDA said in a statement.
“The presence of sildenafil, and 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.
PrimeZen Black 6000 is classified as a food rather than a drug because it is marketed and sold as a dietary supplement. Because of that, it is 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.
Both Viagra and Cialis are used to treat 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.
Nitrates are prescribed for those with diabetes, high blood pressure, high cholesterol and heart disease.
The supplement’s UPC code is 728175521891. The affected PrimeZen Black 6000 includes the lot number [NPINPB 1003] with an expiration date of 08/16/2025.
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