FDA

Undeclared ingredients prompt nationwide recall of Vitality capsules

March 5, 2025

One Source Nutrition, Inc. has issued a voluntary nationwide recall of its Vitality capsules after an FDA analysis detected undeclared sildenafil and tadalafil, which are phosphodiesterase-5 (PDE-5) inhibitors. Consumption of products with undeclared sildenafil or tadalafil may interact with nitrates found in some prescription drugs and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, hypertension, hyperlipidemia, 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.

Vitality capsules, marketed as a male enhancement dietary supplement, are unapproved new drugs with unverified safety and efficacy. The recall affects all lots of the product, which is distributed nationwide in single-pill packages and bottles containing six pills. No adverse events have been reported to date. Clinicians should advise patients to discontinue use immediately and return the product to the place of purchase. For more information, contact One Source Nutrition at 501-778-3311 or via email at onesourcelr@gmail.com.

Source:

(2025, March 3). FDA. One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/one-source-nutrition-inc-issues-voluntary-nationwide-recall-vitality-capsules-due-presence-0