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D-0084-2025Class I

Boulla LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Boulla LLC
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
Nationwide within the United States
Firm state
CA
Product quantity
Unknown
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →