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 the 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.
