FDA Drug recall D-1291-2022
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,…
- FDA Drug
- Class II
- terminated
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,… by Sun Pharmaceutical Industries, citing failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1291-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-27 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
Reason
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Identifiers
| ndc | 62756-796-83 |
|---|---|
| ndc | 62756-796-88 |
| ndc | 62756-796-08 |
| ndc | 62756-796-13 |
| ndc | 62756-796-18 |
| ndc | 62756-797-83 |
| ndc | 62756-797-88 |
| ndc | 62756-797-08 |
| ndc | 62756-797-13 |
| ndc | 62756-797-18 |
| ndc | 62756-798-83 |
| ndc | 62756-798-88 |
| ndc | 62756-798-08 |
| ndc | 62756-798-13 |
| ndc | 62756-798-18 |
| code_info | Lot: HAC1312A, EXP. 05/2024 |
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-1291-2022%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.