Divalproex Sodium Extended-release Tablets — Class II drug recall D-0507-2019
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2019-02-27, distributed nationwide. Failed Dissolution Specifications: Out of specification results observed for high dissolution.
| Recall number | D-0507-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2019-01-31 |
| Classified | 2019-02-15 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2023-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 10,656 bottles |
| Reason classes | specification failure |
| NDC | 55111-0533, 55111-0533-01, 55111-0533-05, 55111-0533-30, 55111-0533-60, 55111-0533-78, 55111-0533-79 |
| Lot numbers | 03/20, C802676 |
Product
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
Reason for recall
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
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-0507-2019. 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.