FDA DrugsClass II
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: S...
Published: January 28, 2026Recall ID: D-0295-2026Category: drugsCountry: US
Reason for Recall / Hazard
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Pennington |
| State | NJ |
| Event id | 98227 |
| Address 1 | 73 Route 31 N |
| Code info | Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027 |
| Postal code | 08534-3601 |
| Report date | 20260128 |
| Product type | Drugs |
| Product quantity | 22,896 bottles |
| Reason for recall | Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251230 |
| Initial firm notification | Letter |
| Center classification date | 20260122 |
Overview
- Recalling FirmZydus Pharmaceuticals (USA) Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.