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Sexual Enhancement Supplement Under Class I Recall
A dietary supplement marketed for male sexual enhancement and sold worldwide on Amazon.com is under a Class I recall after an analysis conducted by the US Food and Drug Administration (FDA) identified nortadalafil, an active drug ingredient known for the treatment of male erectile dysfunction, in the product. The FDA included the recall for Schwinnng capsules in its May 22, 2024, Enforcement Report.
“The Schwinnng products contain nortadalafil, which may 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,” recalling firm Stop Clopez Corp wrote in an April 22, 2024, statement. “People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.”
The recall affects Schwinnng herbal dietary supplement capsules, packaged in 10-count boxes, from lot 2108 (Exp. 10/31/24). The capsules were distributed by VSD Productions Inc., Las Vegas, Nevada.
Stop Clopez Corp voluntarily initiated the recall on April 22, 2024. The FDA issued its Class I designation on May 13, 2024.
When it announced the recall, Stop Clopez Corp said it had received no reports of adverse effects associated with the product’s use.