Divalproex Sodium Delayed Release Tablets — Class II drug recall D-0617-2017
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2017-04-05, distributed nationwide. Failed Dissolution Specifications; 9 month long term stability
| Recall number | D-0617-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2017-03-15 |
| Classified | 2017-03-27 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2020-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 32,628 bottles |
| Reason classes | specification failure |
| NDC | 68382-0033-01, 68382-0033-05 |
| Expiration dates | 2017-05-31, 2017-06-30, 2017-07-31, 2017-08-31, 2017-09-30, 2017-10-31, 2017-11-30 |
Product
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Reason for recall
Failed Dissolution Specifications; 9 month long term stability
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-0617-2017. 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.