Vitality male enhancement dietary supplement - recalled due to Undeclared Ingredient, USA

United States

One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are ingredients in FDA-approved products for the treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing sildenafil and tadalafil cannot be marketed as dietary supplements. Vitality capsules are an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall. Vitality capsules were distributed Nationwide to retail outlets from wholesale distributors.

Risk Statement: Consumption of products with undeclared tadalafil 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. 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, One Source Nutrition, Inc. has not received any reports of adverse events related to this recall.

The tainted Vitality capsules are marketed as a dietary supplement used as a male enhancement product and are packaged in a single pill. The affected Vitality capsules product does not have lot numbers or expiration dates. The product can be identified by a single pill in an orange and gray package with blue writing or found in bottles containing six pills.

One Source Nutrition, Inc. is notifying its distributors and customers by email and is arranging for the return of all recalled products. Retailers that have Vitality capsules which are being recalled should return to the place of purchase/discard/contact their doctor, etc.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers should return all purchased products to the place of purchase.

If you are experiencing symptoms after eating this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/one-source-nutrition-inc-issues-voluntary-nationwide-recall-vitality-capsules-due-presence-0