Vitality male enhancement dietary supplement capsules recall: Undeclared Sildenafil and Tadalafil

What the company announced

“This press release is an update to the company’s press release, previously issued on 02/20/2025, to include all pack styles.”

FOR IMMEDIATE RELEASE – Benton, Arkansas – 03/03/2025 –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 or found in bottles containing six pills. Vitality capsules was distributed Nationwide to retail outlets from wholesale distributor.

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

Consumers with questions regarding this recall can contact One Source Nutrition Inc by 501-778-3311 or [email protected] on Monday thru Friday 10am to 6pm CST .

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 product to place of purchase .

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.