Recall D-0295-2026

US Class II Ongoing · initiated 2025-12-30

Recalling firm

Zydus Pharmaceuticals (USA) Inc, NJ

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

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