Icosapent Ethyl Capsules 1 gram — Class II drug recall D-0497-2025
Completed recall by Zydus Pharmaceuticals (USA) Inc, reported 2025-06-18, distributed in IL, MS, PA. Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was
| Recall number | D-0497-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-05-30 |
| Classified | 2025-06-30 |
| Reported by FDA | 2025-06-18 |
| Distributed | IL, MS, PA |
| Quantity | 11,616 bottles |
| Reason classes | packaging |
| NDC | 70710-1592, 70710-1592-07, 70710-1738, 70710-1738-04 |
| Lot numbers | B237040, B237041 |
| Expiration dates | 2025-10-31 |
Product
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Reason for recall
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
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-0497-2025. 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.