Boulla LLC: Drug Recall

Recall #D-0084-2025 · 11/04/2024

Class I: Dangerous

Recall Details

Recall Number
D-0084-2025
Classification
Class I
Product Type
Drug
Recalling Firm
Boulla LLC
Status
Ongoing
Date Initiated
11/04/2024
Location
Sacramento, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Unknown

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

Distribution Pattern

Nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.