FDA Drugs recall ·
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0281-2025
- Date
- (initiated February 20, 2025)
- Company / brand
- One Source Nutrition, Inc,
19863 Interstate 30 S, Benton, AR, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- a) 300 individually wrapped capsules b) 20 bottles
- Hazard tags
- Undeclared allergen
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Why was it recalled?
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots
Distribution
Nationwide in the U.S.A
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0281-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.