FDA Recall D-0397-2026

StuffbyNainax · Huntsville, TX

Class I — life-threatening Ongoing 150 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7

Lot / code: All codes; Exp 12/31/2029

Quantity: 4

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil

Recall record

Recall number: D-0397-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was distributed to 4 customers in the US.
Recall initiated: 2025-12-15
Classified by FDA Center: 2026-03-18
FDA published: 2026-03-11
Recalling firm: StuffbyNainax
Firm location: Huntsville, TX

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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