Divalproex Sodium Extended-release Tablets — Class II drug recall D-0426-2024
Terminated recall by Amneal Pharmaceuticals of New York, LLC, reported 2024-04-03, distributed nationwide. Failed dissolution specifications
| Recall number | D-0426-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY, United States |
| Recall initiated | 2023-12-26 |
| Classified | 2024-03-27 |
| Reported by FDA | 2024-04-03 |
| Terminated | 2024-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 21,452 |
| Reason classes | specification failure |
| NDC | 65162-0755, 65162-0755-10, 65162-0755-50, 65162-0757, 65162-0757-10, 65162-0757-50 |
| Lot numbers | AR210704, AR210706, AR210707, AR210708, AR210709 |
| Expiration dates | 2024-04 |
Product
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
Reason for recall
Failed dissolution specifications
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-0426-2024. 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.