Divalproex Sodium Extended-Release Tablets — Class II drug recall D-1133-2019
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2019-04-24, distributed nationwide. cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
| Recall number | D-1133-2019 |
|---|---|
| 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 | 2019-04-11 |
| Classified | 2019-04-15 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 33,958 bottles |
| Reason classes | cgmp |
| NDC | 55111-0533-01, 55111-0533-05 |
| Expiration dates | 2020-03, 2020-07, 2020-10 |
Product
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Reason for recall
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
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-1133-2019. 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.