Divalproex Sodium Extended Release Tablets — Class II drug recall D-1362-2022
Terminated recall by Amneal Pharmaceuticals of New York, LLC, reported 2022-08-31, distributed nationwide. Failed dissolution specifications.
| Recall number | D-1362-2022 |
|---|---|
| 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 | 2022-07-27 |
| Classified | 2022-08-19 |
| Reported by FDA | 2022-08-31 |
| Terminated | 2023-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 4,309 bottles |
| Reason classes | specification failure |
| NDC | 65162-0755, 65162-0755-10, 65162-0755-50, 65162-0757, 65162-0757-10, 65162-0757-50 |
| Lot numbers | AR210705 |
| Expiration dates | 2024-04 |
Product
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, 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-1362-2022. 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.