PeakMax Capsules recall — Class I (D-0084-2025) · pharmaranks
Class IOngoing
PeakMax Capsules recall
FDA recall D-0084-2025 · initiated Nov 4, 2024
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Details
Product
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Recalling company
Boulla LLC
Classification
Class I
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide within the United States
Initiated
Nov 4, 2024
FDA report date
Dec 11, 2024
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.