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FDA DrugClass IINotable

FDA Recall: Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthc

Date: 2026-03-18
Brand: Zydus Pharmaceuticals (USA) Inc
Category: Drug
FDA Class: Class II

Description

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

Hazard

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

Remedy

60,541 bottles

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