FDA Drug recall D-1041-2017
Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India,…
- FDA Drug
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India,… by Zydus Pharmaceuticals Usa, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1041-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-10 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
Reason
Failed Dissolution Specifications
Identifiers
| code_info | MR6317 Exp.05/17 MR6318 Exp. 05/17 MR6319 Exp. 05/17 MR5361 Exp. 06/17 MR9007 Exp. 08/17 MR10000 Exp. 08/17 MR109…MR6317 Exp.05/17 MR6318 Exp. 05/17 MR6319 Exp. 05/17 MR5361 Exp. 06/17 MR9007 Exp. 08/17 MR10000 Exp. 08/17 MR10923 Exp. 10/17 MR10924 Exp. 10/17 MR10925 Exp. 10/17 MR11554 Exp. 11/17 MR11555 Exp. 11/17 MS1359 Exp. 12/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1041-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.