Product: Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Reason for recall: 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.
Recall initiated: 20250530
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated