FDA Drug recall D-0426-2024
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt
- FDA Drug
- Class II
- terminated
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt by Amneal Pharmaceuticals, citing failed dissolution specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0426-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-12-26 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
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
Failed dissolution specifications
Identifiers
| ndc | 65162-755-10 |
|---|---|
| ndc | 65162-755-50 |
| ndc | 65162-757-10 |
| ndc | 65162-757-50 |
| code_info | Lot # AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0426-2024%22
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