Brand
Zydus
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Zydus and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-18FDA-DrugClass IIIcosapent 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
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
- 2026-01-28FDA-DrugClass IIStop using Zydus Icosapent Ethyl capsules
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- 2025-10-08FDA-DrugClass IIStop using Zydus Entecavir tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
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