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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- undeclared-sildenafil
- undeclared-diclofenac
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.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- ModerateFentanyl Citrate Sterile Injection Recalled for Subpotent Drug Content
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27