PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
What was recalled
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
- Recalling firm
- Boulla LLC
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0084-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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