FDA Drug recall D-1583-2019
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laborator…
- FDA Drug
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laborator… by Major Pharmaceuticals, citing cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1583-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-24 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Major Pharmaceuticals |
| Distribution | US |
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
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Identifiers
| ndc | 0904-6363-45 |
|---|---|
| ndc | 0904-6363-61 |
| code_info | Lot# M02250 EXP 10/2020. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1583-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.