Male performance enhancers recalled over prescription medication contamination concerns: FDA

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A company is calling back two kinds of its male performance enhancer supplements because they are contaminated with prescription medication, according to a recall notice.

Adam’s Secret in a recall notice posted on the U.S. Food and Drug Administration’s (FDA) website on Tuesday said it is voluntarily recalling “all lots within expiry” of Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules after an FDA laboratory analysis found that they contained undeclared sildenafil and/or tadalafil.

Adam’s Secret in a recall notice posted on the U.S. Food and Drug Administration’s (FDA) website on Tuesday said it is voluntarily recalling “all lots within expiry” of Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules (iStock)

“Sildenafil and tadalafil are ingredients in FDA-approved products for the treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of sildenafil and/or tadalafil in Adam’s Secret Extra Strength products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall,” the recall notice reads.

Though no adverse events related to the recall have been reported to date, those with underlying medical issues who take one of the recalled products  “may experience serious health risks,” officials said. “For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.”

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The products, which were marketed as dietary supplements for male sexual enhancement, were sold nationwide through the company’s website.

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The company is notifying its customers who may have purchased one of the affected products via email to arrange a return. In the meantime, consumers who purchased Adam’s Secret Extra Strength 1500 or 3000 should stop using it.

More information on the recall can be found here.

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