FDAClass IDecember 11, 2024

PeakMax Capsules recall

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

Why was PeakMax Capsules recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Recalling firm
Boulla LLC
Quantity
Unknown
Distribution
Nationwide within the United States
Recall date
December 11, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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