Zydus Pharmaceuticals recalls Icosapent Ethyl capsules due to burnt or melted capsules from oxidation. Affected lots manufactured in Italy, distributed in the US. Stop using if capsules appear burnt or melted.
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Zydus Pharmaceuticals is recalling Icosapent Ethyl capsules that may have burnt or melted due to oxidation. This could cause the capsules to fail in their intended use, potentially leading to ineffective treatment.
The capsules may burn or melt due to oxidation from leakage of their contents. This can cause the product to fail in its intended use, meaning it might not work as prescribed.
Prescription users of Icosapent Ethyl capsules in the US. Those with the specific lot numbers B237040 or B237041 are most at risk.
Check for burnt or melted capsules. The affected product is Icosapent Ethyl 1 gram capsules, 120 per bottle, with lot numbers B237040 or B237041, manufactured in Italy and distributed by Zydus Pharmaceuticals in the US.
Inspect capsules for signs of burning or melting. If present, stop using the product immediately.
The recall indicates a risk of burnt or melted capsules due to oxidation. If capsules appear burnt or melted, stop using them immediately.
Lot numbers B237040 and B237041 are affected.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0497-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0497-2025 from Zydus Pharmaceuticals. 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.
