FDA Drug recall D-1362-2022
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, In…
- FDA Drug
- Class II
- terminated
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class II recall of Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, In… by Amneal Pharmaceuticals, citing failed dissolution specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1362-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-07-27 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
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
Failed dissolution specifications.
Identifiers
| ndc | 65162-755-10 |
|---|---|
| ndc | 65162-755-50 |
| ndc | 65162-757-10 |
| ndc | 65162-757-50 |
| code_info | Lot #: AR210705, Exp 04/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1362-2022%22
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