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

FDA Recall #D-0084-2025 — Class I — November 4, 2024

Recall #D-0084-2025 Date: November 4, 2024 Classification: Class I Status: Ongoing

Product Description

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.

Recalling Firm

Boulla LLC — Sacramento, CA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

Unknown

Distribution

Nationwide within the United States

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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