FDA Drug recall D-1136-2015
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd
- FDA Drug
- Class II
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class II recall of Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd by Dr Reddy S Laboratories, citing failed Dissolution Specifications; exceeded specification at the 9 hour time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1136-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-22 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
Reason
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Identifiers
| ndc | 55111-534-30 |
|---|---|
| ndc | 55111-534-60 |
| ndc | 55111-534-01 |
| ndc | 55111-534-05 |
| code_info | Lot #C308195, exp 10/2015 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1136-2015%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.