Icosapent Ethyl Capsules Class II Recall

FDA: Drug Recalls Class II

Filed March 18th, 2026

Detected March 23rd, 2026

Summary

The FDA is reporting an ongoing Class II recall for Icosapent Ethyl Capsules initiated by Zydus Pharmaceuticals (USA) Inc. The recall is due to the presence of red dots inside capsules and melted capsules caused by oxidized Icosapent ethyl, the active ingredient. Approximately 60,541 bottles are affected.

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What changed

Zydus Pharmaceuticals (USA) Inc. has initiated a voluntary Class II recall for Icosapent Ethyl Capsules (1 gram, 120 capsules per bottle) due to a quality issue where the active ingredient, Icosapent ethyl, has oxidized, leading to red dots inside the capsules and melted capsules. This recall affects approximately 60,541 bottles distributed nationwide in the USA. The affected lots have expiration dates ranging from January 2027 to April 2027.

Regulated entities, particularly distributors and pharmacies handling this product, should verify their inventory for the affected lots and follow the recall procedures outlined by Zydus Pharmaceuticals. Failure to comply with recall procedures can result in regulatory action from the FDA. While this is a voluntary recall, the FDA's classification indicates a lower risk to health than a Class I recall, but prompt action is still necessary to prevent patient exposure to potentially compromised medication.

What to do next

Verify inventory for affected lots of Icosapent Ethyl Capsules.
Follow recall procedures outlined by Zydus Pharmaceuticals (USA) Inc.
Report any findings or actions taken regarding the recall to the appropriate regulatory channels.

Source document (simplified)

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