PeakMax Capsules recalled over undeclared sildenafil

Recall date

November 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Boulla LLC recalls PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.Pea…

Recall number

D-0084-2025

FDA classification

Class I

Brand / firm

Boulla LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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