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
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 30, 2025 |
| Reported | January 28, 2026 |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Country / region | United States NJ |
Hazard
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Affected products
- Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA)
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