Boulla PeakMax Capsules Recall: FDA Class I

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide within the United States

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0084-2025
Classification: Class I
Status: Ongoing
Recall initiated: Nov 4, 2024
FDA report date: Dec 11, 2024
Quantity: Unknown
Recall type: Voluntary: Firm initiated
Recalling firm: Boulla LLC

Original FDA data

Every field from FDA enforcement report D-0084-2025, exactly as published.

Show all FDA fields

City: Sacramento
State: CA
Status: Ongoing
Country: United States
Event ID: 95714
Address: 2108 N ST #7929
Code information: Lot #: 230811, Exp: 08/11/2025
Postal code: 95816
Report date: Dec 11, 2024
Product type: Drugs
Recall number: D-0084-2025
Classification: Class I
Recalling firm: Boulla LLC
Product quantity: Unknown
Reason for recall: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Voluntary / mandated: Voluntary: Firm initiated
Product description: PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Distribution pattern: Nationwide within the United States
Recall initiation date: Nov 4, 2024
Initial firm notification: E-Mail
Center classification date: Dec 2, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0084-2025, published Dec 11, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Boulla PeakMax Capsules Recall

Summary