PeakMax recalls 500mg capsules with undeclared sildenafil and diclofenac. Products may contain harmful ingredients without FDA approval. Consumers should stop using and contact the company.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
PeakMax is recalling 500mg capsules that contain undeclared sildenafil and diclofenac. These ingredients were not approved by the FDA, which could pose health risks to users.
The capsules contain sildenafil (an erectile dysfunction drug) and diclofenac (a painkiller) without proper FDA approval. These ingredients can cause serious health issues like heart problems or allergic reactions when taken without medical supervision.
Anyone who owns or uses PeakMax 500mg capsules. People with heart conditions or who take blood thinners are at higher risk due to the undeclared medications.
Check for PeakMax 500mg capsules in 10-count blister packs. The lot number 230811 was distributed by PeakMax in San Francisco, CA, with an expiration date of August 11, 2025.
Immediately stop using the recalled PeakMax 500mg capsules as they contain undeclared medications that could cause health risks.
No, the capsules contain undeclared sildenafil and diclofenac without FDA approval, which could cause serious health risks.
Look for PeakMax 500mg capsules in 10-count blister packs with lot number 230811, distributed by PeakMax in San Francisco, CA, expiring August 11, 2025.
Immediately stop using the product and contact PeakMax at www.PeakMax.com for further instructions.
We’ve drafted a message you can send PeakMax to request your refund or repair — edit it as you like.
Subject: Recall D-0084-2025 — PeakMax PeakMax Hello, I own a PeakMax that is covered by recall D-0084-2025 from PeakMax. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
