Adamssecret.co has recalled all lots within expiry of Adam's Secret Extra Strength 1500 and Adam's Secret Extra Strength 3000 in the form of capsules, the U.S. Food and Drug Administration or FDA said in a statement. The product is marketed as a dietary supplement for male sexual enhancement.
The company initiated the recall after it was found in an FDA analysis that the product contains undeclared sildenafil and/or tadalafil, which are ingredients in FDA-approved products for the treatment of male erectile dysfunction.
The presence of sildenafil and/or tadalafil in Adam's Secret Extra Strength products makes them new drugs which are unapproved by the FDA and for which the safety and efficacy have not been established.
The FDA said there have been no reports of adverse events received involving the recalled lot, which was distributed via internet at www.adamssecret.co across the U.S. The recalled product was packaged in blister foil sheets and in a box containing 10 capsules.
adamssecret.co warned that consumers with underlying medical issues who take the capsules with undeclared sildenafil and tadalafil may experience serious health risks. The company said the administration of the product containing sildenafil and/or tadalafil could lower blood pressure to dangerous levels that may be life-threatening.
These two ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
adamssecret.co has urged consumers who have Adam's Secret Extra Strength 1500 or 3000, which are under recall, to stop using them and return to place of purchase.
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