One Source Nutrition has issued a nationwide recall of all lots of its Vitality capsules after U.S. Food and Drug Administration testing found the product contains sildenafil and tadalafil, active ingredients in prescription drugs used to treat erectile dysfunction.

The recall, announced at the consumer level, follows FDA regulations that prohibit dietary supplements from containing these pharmaceutical compounds.

Vitality capsules, marketed as a male enhancement supplement, are considered an unapproved new drug with no established safety or efficacy. The capsules, sold in single-pill orange and gray packages with blue writing or in bottles containing six pills, were distributed nationwide through wholesale distributors to retail outlets. The product does not have lot numbers or expiration dates.

According to the FDA, undeclared tadalafil poses a significant health risk, particularly to individuals taking nitrates for conditions such as high blood pressure, diabetes, high cholesterol, or heart disease. Combining tadalafil with nitrates can cause a dangerous drop in blood pressure, which may be life-threatening. The primary consumers of this product — adult males — are among those most at risk.

One Source Nutrition has not received any reports of adverse reactions related to the recall. The company is notifying distributors and customers by email and coordinating the return of all affected products. Retailers are advised to return the recalled supplements to the place of purchase or dispose of them properly.

For more information, visit www.fda.gov/safety/recalls-market-withdrawals-safety-alerts or contact One Source Nutrition customer service.