Product: ICOSAPENT ETHYL Classification: Class II Reason for recall: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. Product description: Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt.
Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7 Recalling firm: Zydus Pharmaceuticals (USA) Inc Product type: Drugs
FDA MedWatch published a clinical safety alert in Pharmacology on 18 Mar 2026.
The item focuses on ICOSAPENT ETHYL: Class II recall update.
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