FDA Recall D-0084-2025

Boulla LLC · Sacramento, CA

Class I — life-threatening Ongoing 556 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

PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com

Lot / code: Lot #: 230811, Exp: 08/11/2025

Quantity: Unknown

Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Recall record

Recall number: D-0084-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide within the United States
Recall initiated: 2024-11-04
Classified by FDA Center: 2024-12-02
FDA published: 2024-12-11
Recalling firm: Boulla LLC
Firm location: Sacramento, CA

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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