Vitality Male Enhancement Supplement Recalled Due to Undeclared Drug Ingredients

One Source Nutrition, Inc. has voluntarily recalled its product Vitality, fast acting male enhancement, distributed as both single capsule packets and bottles containing 6 capsules, due to the presence of undeclared pharmaceutical ingredients. The recall affects all lots of the supplement, which was distributed nationwide in the US. The US Food and Drug Administration (FDA) classified this as a Class I recall, the most serious type, indicating that use of the product could cause serious adverse health consequences or death.

The recall was initiated after testing revealed that Vitality was tainted with undeclared sildenafil and tadalafil, the active ingredients found in FDA-approved prescription drugs for erectile dysfunction. These ingredients can interact dangerously with certain prescription medications, particularly nitrates, and pose a risk to consumers with underlying cardiovascular conditions. Because the product is marketed as a dietary supplement and lacks an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is considered an unapproved drug and therefore illegal.

Sildenafil and tadalafil are phosphodiesterase type 5 (PDE5) inhibitors approved by the FDA for the treatment of erectile dysfunction (ED) in men. These drugs enhance blood flow to the penis, helping to achieve and maintain an erection. While effective under medical supervision, their presence in unregulated supplements without proper labeling or dosing guidance poses significant risks to patients and undermines safe pharmaceutical practice.