FDA recall D-0084-2025

Boulla LLC · Class I · drug

Product

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2024-11-04
Report date
2024-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sacramento, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0084-2025