FDA Recall D-0281-2025

One Source Nutrition, Inc, · Benton, AR

Class I — life-threatening Ongoing 448 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

Lot / code: All lots

Quantity: a) 300 individually wrapped capsules b) 20 bottles

Reason for recall

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

Recall record

Recall number: D-0281-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the U.S.A
Recall initiated: 2025-02-20
Classified by FDA Center: 2025-03-17
FDA published: 2025-03-26
Recalling firm: One Source Nutrition, Inc,
Firm location: Benton, AR

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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