Product: Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Reason for recall: Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Recall initiated: 20251230
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated