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

Recall Number: D-0295-2026

Firm: Zydus Pharmaceuticals (USA) Inc

Classification: Class II

Status: Ongoing

Report Date: 20260128

Initiation Date: 20251230

Termination Date:

Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules

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