FDA Drug recall D-0365-2022
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd
- FDA Drug
- Class II
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class II recall of Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd by Torrent Pharma, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0365-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-02 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
Product
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 13668-268-30 |
|---|---|
| ndc | 13668-268-01 |
| ndc | 13668-268-10 |
| ndc | 13668-268-31 |
| ndc | 13668-268-05 |
| ndc | 13668-271-01 |
| ndc | 13668-271-10 |
| ndc | 13668-271-49 |
| ndc | 13668-271-05 |
| code_info | Batch: 4J11G002 Exp. 08/2024 |
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-0365-2022%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.