Icosapent Ethyl capsules — Class II drug recall D-0295-2026
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2026-01-28, distributed nationwide. Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
| Recall number | D-0295-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-12-30 |
| Classified | 2026-01-22 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 22,896 bottles |
| Reason classes | potency, packaging |
| NDC | 70710-1592-07 |
| Lot numbers | S2520304, S2520333, S2540186 |
| Expiration dates | 2027-02-28, 2027-04-30 |
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 for recall
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0295-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.