FDA Drug recall D-0507-2019
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 50…
- FDA Drug
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 50… by Dr Reddy S Laboratories, citing failed Dissolution Specifications: Out of specification results observed for high dissolution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0507-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-31 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Identifiers
| ndc | 55111-533-30 |
|---|---|
| ndc | 55111-533-60 |
| ndc | 55111-533-01 |
| ndc | 55111-533-05 |
| ndc | 55111-533-79 |
| ndc | 55111-533-78 |
| code_info | Lot #: C802676, Exp 03/20 |
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-0507-2019%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.