Class II Recall

Zydus Pharmaceuticals (USA) Inc

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
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Classification
Class II
Status
Ongoing
Lot
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Zydus Pharmaceuticals (USA) Inc — Class II Recall | MedicineWatch US