Icosapent Ethyl Capsules — Class II drug recall D-0400-2026
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2026-03-18, distributed nationwide. Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent
| Recall number | D-0400-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2026-03-09 |
| Classified | 2026-03-20 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 60,541 bottles |
| NDC | 70710-1592, 70710-1592-07, 70710-1738, 70710-1738-04 |
| Lot numbers | 2027/APR, 2027/FEB, 2027/JAN, S2520249, S2520250, S2520267, S2520303, S2520305, S2520332, S2540208, S2540209 |
Product
Icosapent 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
Reason for recall
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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-0400-2026. 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.