Warning
Zydus Pharmaceuticals (USA) Inc Recalls Icosapent Ethyl capsules
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0295-2026Drug / Pharmaceutical
Zydus Pharmaceuticals (USA) Inc Recalls Icosapent Ethyl capsules
Zydus Pharmaceuticals (USA) Inc · Class II — Moderate Risk
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
Reason for Recall
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database