Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India
Recalled March 18, 2026 · FDA recall D-0400-2026 · Zydus Pharmaceuticals (USA)
Hazard
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. · FDA Class II
Units
60,541 bottles
Sold at
Nationwide in the USA
Description
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Product
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →