Divalproex Sodium Extended-Release Tablets — Class II drug recall D-1135-2015
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2015-06-24, distributed nationwide. Failed Dissolution Specifications; exceeded specification at the 9 hour time point
| Recall number | D-1135-2015 |
|---|---|
| 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 | 2015-05-22 |
| Classified | 2015-06-12 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2017-04-24 |
| Distributed | Nationwide (US) |
| 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 | 500, C307812, C307859 |
| Expiration dates | 2015-09 |
Product
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Reason for recall
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
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-1135-2015. 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.