Class IIReported 2025-06-18

Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.

Reason for Recall

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules

This was determined to be a result of oxidation by leakage of capsule contents.

Recall Number

D-0497-2025

Classification

Class II

Status

Ongoing