Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Dis…

Recall date

December 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0295-2026

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals (USA) Inc

Sold / distributed

US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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