Divalproex Sodium Delayed-Release Tablets — Class II drug recall D-1291-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-08-03, distributed nationwide. Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
| Recall number | D-1291-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-06-27 |
| Classified | 2022-07-26 |
| Reported by FDA | 2022-08-03 |
| Terminated | 2023-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 9,552 bottles |
| Reason classes | specification failure |
| NDC | 62756-0796, 62756-0796-08, 62756-0796-13, 62756-0796-18, 62756-0796-83, 62756-0796-88, 62756-0797, 62756-0797-08, 62756-0797-13, 62756-0797-18, 62756-0797-83, 62756-0797-88, 62756-0798, 62756-0798-08, 62756-0798-13, 62756-0798-18, 62756-0798-83, 62756-0798-88 |
| Lot numbers | HAC1312A |
| Expiration dates | 2024-05 |
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 for recall
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1291-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.