Divalproex Sodium Delayed Release Tablets — Class II drug recall D-1043-2017
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2017-08-09, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1043-2017 |
|---|---|
| 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 | 108,726 hdpe |
| Reason classes | specification failure |
| NDC | 68382-0033-01, 68382-0033-05 |
Product
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
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-1043-2017. 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.