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.
411 Press Analysis
Zydus Pharmaceuticals (USA) Inc has recalled a pharmaceutical product that the FDA classified as Class II affecting 22,896 bottles. The recall was initiated on December 30, 2025. Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules. It was distributed in US Nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.