FDA recalls male sexual enhancement supplements over undeclared drug ingredients

1 of 3 | The FDA announced a recall of Today The World’s Schwinnng supplement capsules as they contained undeclared drugs used to treat male erectile dysfunction. Photo courtesy of FDA

Feb. 6 (UPI) — A Washington-based company has issued voluntary recalls of several dietary supplements marketed for male sexual enhancement that the U.S. Food and Drug Administration said contained undeclared drug ingredients.

Both recalls by Today The World, based in Vancouver, Wash., were announced Monday by the FDA over the products’ undeclared inclusion of tadalafil and/or its structurally similar nortadalafil, which are used to treat male erectile dysfunction.

The first recall concerns Sustain herbal dietary supplement capsules and Schwinnng capsules, which were found to contain undeclared tadalafil and nortadalafil.

The Sustain products have an expiration date of May 15, 2026, and are coded as BTH:230551, EXP:12.05.2026 and BTH: 230571.

The Schwinnng product has an expiration date of Oct. 2024.

The products were sold online, via Amazon or the individual brand’s websites.

The second recall affects Arize Herbal Dietary Supplement capsules that have an expiration date of Oct. 2024 and were distributed via www.getarize.com website in the United States. This product was found to only contain dnortadalafil.

“Consumption of products with undeclared tadalafil or nortadalafil 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,” the FDA said.

“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.”

To date, there have been no adverse events reported with any of the products.

In a statement distributed by the FDA, Today The World said it is committed to improving its products and avoiding future recalls by sourcing higher-quality raw ingredients and expanding testing.

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