Zydus Pharmaceuticals recalls Icosapent Ethyl capsules with red dots and melted capsules due to oxidized active ingredient. Stop using affected lots before 2027.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Zydus Pharmaceuticals recalls Icosapent Ethyl capsules that may have red dots inside and melted capsules due to oxidized active ingredient. This could cause improper drug delivery and potential health risks if used.
The capsules may contain red dots and melted shells due to oxidized Icosapent ethyl. This could lead to improper drug delivery and potential health risks if used.
People with prescriptions for Icosapent Ethyl capsules from Zydus Pharmaceuticals (USA) Inc. Those who received capsules with specific lot numbers and expiration dates listed in the recall are most at risk.
Check the product label for the lot numbers: S2520249, S2520250, S2520267 (expiring Jan 2027), S2520303, S2520305, S2520332 (expiring Feb 2027), or S2540208, S2540209 (expiring Apr 2027).
Look for lot numbers S2520249, S2520250, S2520267 (expiring Jan 2027), S2520303, S2520305, S2520332 (expiring Feb 2027), or S2540208, S2540209 (expiring Apr 2027).
The capsules may have red dots inside and melted shells due to oxidized Icosapent ethyl, which could lead to improper drug delivery.
Check the product label for the specific lot numbers listed in the recall. If you have them, stop using and contact Zydus Pharmaceuticals for instructions.
The recall is due to potential improper drug delivery from oxidized active ingredient, but the risk level is low as the remedy does not require immediate discontinuation.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0400-2026 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0400-2026 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.
