PeakMax Capsules Recalled for Undeclared Sildenafil and Diclofenac
PeakMax Capsules contain undeclared sildenafil and diclofenac and were marketed without FDA approval. This Class I recall affects capsules distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall for an unapproved drug product containing undeclared ingredients. While no illnesses or injuries have been reported, Class I status mandates a minimum severity score of 4 per the rubric requirement that FDA Class I recalls never score below 4.
Plain-English summary
PeakMax Capsules 500 mg are being recalled. The product was marketed without the required FDA approval through a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules contain sildenafil and diclofenac, which were not declared on the product labeling.
The product was distributed nationwide in the United States in 10-count blister packs. The recalled lot is #230811 with an expiration date of August 11, 2025. It was manufactured by Boulla LLC and distributed by PeakMax of San Francisco, California.
This is classified as a Class I FDA recall. The recall was initiated because the product was marketed without proper FDA approval and contains undeclared ingredients.
The recalled product
- Product
- PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
- Manufacturer
- Boulla LLC
- Category
- Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 230811
- Exp: 08/11/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Boulla LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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