FDA Drug recall D-0295-2026
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt
- FDA Drug
- Class II
- ongoing
- Published 2026-01-28
On 2026-01-28 the FDA classified a Class II recall of Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt by Zydus Pharmaceuticals Usa, citing subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0295-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-30 |
| Published | 2026-01-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
Reason
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Identifiers
| code_info | Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0295-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.