Class II

Drug Recall: 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 70710-15

Zydus Pharmaceuticals (USA) Inc · December 30, 2025

Reason for Recall

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

Product Description

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

Distribution

US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

22,896 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0295-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.