Vitality male enhancement dietary supplement capsules recalled due to Undeclared Ingredients, 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. Vitality capsules were distributed Nationwide to retail outlets from wholesale distributors.

Products containing sildenafil and tadalafil cannot be marketed as dietary supplements. Vitality capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

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.

RECALLED PRODUCT:
- The tainted Vitality capsules is marketed as a dietary supplement
- Used as a male enhancement product
- Is 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.

One Source Nutrition, Inc. is informing its distributors and customers via email and coordinating the return of all affected products. Retailers with recalled Vitality capsules should return them to the original place of purchase, dispose of them properly, or consult a healthcare professional if needed.

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.

Company name: One Source Nutrition
Brand name: Vitality
Product recalled: Vitality male enhancement dietary supplement capsules
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: February 20, 2025

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