What happened
Original notice title
One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
From the archived source record
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. More Recalls, Market Withdrawals, & Safety Alerts Recalls, Market Withdrawals, & Safety Alerts Recall Resources Enforcement Reports Industry Guidance For Recalls Major Product Recalls FOR IMMEDIATE RELEASE – Benton, Arkansas – 02/2025 –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 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 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. The tainted Vitality capsules is marketed as a dietary supplement used as a male enhancement product and 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. Vitality capsules was distributed Nationwide to retail outlets from wholesale distributor.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Published recall notice
- Source checked
- Jul 16, 2026
- Record revision
- cef7bb01e722
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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