FDA Recall D-0396-2026

Mohamed Hagar · Brooklyn Ctr, MN

Class I — life-threatening Ongoing 218 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

Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0

Lot / code: ALL LOTS, exp 12/31/2027

Quantity: 125 boxes

Reason for recall

Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).

Recall record

Recall number: D-0396-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: U.S. Nationwide
Recall initiated: 2025-10-08
Classified by FDA Center: 2026-03-17
FDA published: 2026-03-11
Recalling firm: Mohamed Hagar
Firm location: Brooklyn Ctr, MN

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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