Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
One Source Nutrition, Inc. has issued a voluntary nationwide recall of its Vitality male enhancement dietary supplement capsules after FDA testing revealed the presence of undeclared sildenafil and tadalafil, active ingredients found in prescription drugs used to treat erectile dysfunction. The recall, which includes all lots of Vitality capsules, was initiated due to the potential health risks posed by these undeclared substances.
Health Risks and Concerns
Sildenafil and tadalafil, both phosphodiesterase-5 (PDE-5) inhibitors, are not approved for use in dietary supplements and can pose serious health risks, particularly for individuals taking nitrates for heart conditions. When combined with nitrates, these ingredients can cause a dangerous drop in blood pressure, which may be life-threatening. Men with diabetes, high blood pressure, high cholesterol, or heart disease are especially at risk, as they are more likely to use nitrate medications.
To date, One Source Nutrition has not received any reports of adverse events related to the recalled product. However, consumers are urged to stop using the product immediately and consult their healthcare provider if they have experienced any health issues.
Product Details
The recalled Vitality capsules are marketed as a male enhancement dietary supplement and are sold in two packaging formats:
- A single pill in an orange and gray package with blue writing.
- Bottles containing six pills.
The affected product does not include lot numbers or expiration dates. Vitality capsules were distributed nationwide to retail outlets through wholesale distributors.
What Consumers Should Do
Consumers who have purchased Vitality capsules are advised to stop using the product and return it to the place of purchase for a refund. Those with questions about the recall can contact One Source Nutrition at 501-778-3311 or via email at onesourcelr@gmail.com, Monday through Friday, 10 a.m. to 6 p.m. CST.
Individuals who have experienced adverse reactions or quality issues related to the product are encouraged to report them to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online at www.fda.gov/medwatch/report.htm or by downloading a form from www.fda.gov/MedWatch/getforms.htm and mailing or faxing it to the FDA.
One Source Nutrition is notifying its distributors and customers about the recall via email and is arranging for the return of all affected products. The company is working closely with the FDA to ensure the safety of its consumers and prevent further distribution of the tainted product.
