FDA Drug recall D-1135-2015
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-53…
- 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, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-53… 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-1135-2015 |
| 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, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Reason
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
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 | 100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015 |
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-1135-2015%22
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