One Source Nutrition Recalls Vitality Capsules Due to Undeclared Drug Ingredients

One Source Nutrition, Inc. has issued a voluntary nationwide recall of its Vitality male enhancement dietary supplement capsules after U.S. Food and Drug Administration (FDA) testing revealed the presence of undeclared sildenafil and tadalafil. These ingredients, commonly used in FDA-approved medications to treat erectile dysfunction, are not permitted in dietary supplements. The recall affects all lots of the product, which is considered an unapproved new drug with unverified safety and efficacy.

The company warns that consuming products containing undeclared tadalafil could pose serious health risks, particularly for individuals taking prescription nitrates for conditions such as heart disease, high blood pressure, high cholesterol, or diabetes. The interaction between tadalafil and nitrates can cause a dangerous drop in blood pressure, which may be life-threatening. While no adverse events have been reported to date, the company urges consumers to discontinue use immediately.

The recalled Vitality capsules were distributed nationwide through retail outlets. The product is identifiable by its single-pill packaging, which features an orange and gray design with blue writing. It does not have lot numbers or expiration dates. One Source Nutrition is notifying distributors and customers via email and coordinating the return of all recalled products.

Consumers who have purchased the affected product are advised to return it to the place of purchase and consult a healthcare professional if they experience any health concerns. Adverse reactions or quality issues can be reported to the FDA’s MedWatch Adverse Event Reporting program online or via mail and fax. The recall is being conducted with the knowledge of the FDA.

Article by multiple RFHC contributors.

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