Divalproex Sodium Delayed Release Tablets — Class II drug recall D-1041-2017
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2017-08-09, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1041-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2017-05-10 |
| Classified | 2017-07-31 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2020-01-07 |
| Distributed | Nationwide (US) |
| Quantity | 108,096 hdpe |
| Reason classes | specification failure |
| NDC | 68382-0031-01 |
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 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-1041-2017. 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.