Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Dist
Recalled January 28, 2026 · FDA recall D-0295-2026 · Zydus Pharmaceuticals (USA)
Hazard
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules · FDA Class II
Units
22,896 bottles
Sold at
US Nationwide.
Description
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Product
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
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →