Dietary Supplement Tainted with Undeclared Sildenafil and Tadalafil
Vitality male enhancement dietary supplement recalled nationwide. Product contains undeclared prescription drugs sildenafil and tadalafil not disclosed to consumers.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. The product contains undeclared prescription drugs posing serious health risks through potential drug interactions, overdose, and adverse effects. No reported deaths or hospitalizations are documented.
Plain-English summary
Vitality, a dietary supplement marketed as a fast-acting male enhancement product, is being recalled by the FDA nationwide. The supplement is sold in two forms: individual capsule packets and bottles containing 6 capsules each, labeled as "Xtreme Potency."
The FDA investigation found that the product contains undeclared sildenafil and tadalafil, both prescription medications. These drugs were not listed on the product label or marketing materials. The product was distributed and sold without FDA approval.
Consumers who have purchased Vitality should not use the product. The presence of undeclared prescription medications poses serious health risks, including potential drug interactions with other medications, overdose, and adverse effects. Consumers should consult their healthcare provider if they have used this product and are concerned about their health.
The recalled product
- Product
- Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
- Manufacturer
- One Source Nutrition, Inc,
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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