DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS — Class II drug recall D-1583-2019
Terminated recall by MAJOR PHARMACEUTICALS, reported 2019-08-07, distributed nationwide. cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
| Recall number | D-1583-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | MAJOR PHARMACEUTICALS, Livonia, MI, United States |
| Recall initiated | 2019-04-24 |
| Classified | 2019-08-01 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2020-07-16 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 00904-6363, 00904-6363-45, 00904-6363-61 |
| Lot numbers | M02250 |
| Expiration dates | 2020-10 |
Product
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
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-1583-2019. 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.