Recall D-0400-2026

US Class II Ongoing · initiated 2026-03-09

Recalling firm

Zydus Pharmaceuticals (USA) Inc, NJ

Product

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7

Reason for recall

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

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