Tejal Somvanshi
One Source Nutrition has issued a voluntary nationwide recall of all Vitality male enhancement capsules after FDA tests found them to contain sildenafil and tadalafil – prescription drugs used to treat erectile dysfunction that weren’t disclosed on the product label.
The March 3 announcement expands on the company’s initial February 20 recall to include all packaging styles of the product. The capsules were distributed to retail outlets across the country by wholesale distributors.
Health Risks Prompt Urgent Action
The FDA warns that these undeclared ingredients pose serious health risks. Tadalafil can interact with nitrates found in some prescription medications (such as nitroglycerin), potentially causing a dangerous drop in blood pressure. This interaction is particularly risky for men with diabetes, high blood pressure, high cholesterol, or heart disease – precisely the demographic most likely to use both nitrates and male enhancement products.
“Products containing sildenafil and tadalafil cannot be marketed as dietary supplements,” the FDA notes in the recall notice. The agency classifies Vitality capsules as “an unapproved new drug for which safety and efficacy have not been established.”
Identifying Affected Products
Consumers should look for Vitality capsules packaged either:
- As a single pill in an orange and gray package with blue writing, or
- In bottles containing six pills
The products lack lot numbers or expiration dates, making the packaging the primary means of identification.
Similar Post
Company Response
One Source Nutrition is notifying distributors and customers via email and arranging for the return of all recalled products. According to the company’s statement, no adverse events related to the recall have been reported so far.
Consumers with questions can contact One Source Nutrition at 501-778-3311 or [email protected] on weekdays between 10 a.m. and 6 p.m. CST.
Consumer Action Steps
Anyone who purchased Vitality capsules should:
- Stop using the product immediately
- Return it to the place of purchase
- Contact their healthcare provider if they’ve experienced any adverse effects
Adverse reactions can be reported to the FDA’s MedWatch Adverse Event Reporting program.
Industry Context
This recall highlights the ongoing challenge of undeclared pharmaceutical ingredients in dietary supplements, particularly in the male enhancement category. The FDA regularly identifies such products through its testing program, as supplements marketed for sexual enhancement, weight loss, and bodybuilding are most likely to contain hidden drug ingredients.
FAQ :
What exactly is being recalled and why?
All lots of Vitality male enhancement dietary supplement capsules are being recalled because FDA testing found they contain undeclared sildenafil and tadalafil, which are prescription drugs used to treat erectile dysfunction. These ingredients cannot legally be included in dietary supplements and pose serious health risks when not used under medical supervision.
How can I identify if I have the recalled product?
The recalled Vitality capsules come either as a single pill in an orange and gray package with blue writing or in bottles containing six pills. The products don’t have lot numbers or expiration dates, so identification is primarily by packaging appearance.
What health risks are associated with this recall?
The main health risk is that the undeclared tadalafil can interact with nitrates found in some prescription drugs (like nitroglycerin), potentially causing a life-threatening drop in blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates are at highest risk, particularly adult males.
What should I do if I have the recalled product?
Stop using the product immediately, return it to the place of purchase, and contact your doctor if you’ve experienced any adverse effects. You can also report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program.
Has anyone been harmed by using this product?
According to One Source Nutrition’s statement in the FDA recall notice, no adverse events related to this recall have been reported as of March 3, 2025.
How can I contact the company about this recall?
Consumers with questions can contact One Source Nutrition Inc. at 501-778-3311 or email [email protected] Monday through Friday from 10am to 6pm CST.
