FDA Drug · D-0295-2026

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

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027

Recalling firm: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 22,896 bottles
Distribution: US Nationwide.
Recall initiated: December 30, 2025
Classified: January 22, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0295-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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