FDA Drug recall D-1081-2014
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class II recall of Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only by Caraco Pharmaceutical Laboratories, citing failed Tablet Specifications: Broken Tablets Present.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1081-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-29 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Caraco Pharmaceutical Laboratories |
| Distribution | US |
Product
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI....
Reason
Failed Tablet Specifications: Broken Tablets Present.
Identifiers
| ndc | 62756-183-83 |
|---|---|
| ndc | 62756-183-88 |
| ndc | 62756-183-08 |
| ndc | 62756-183-13 |
| ndc | 62756-183-18 |
| ndc | 62756-184-83 |
| ndc | 62756-184-88 |
| ndc | 62756-184-08 |
| ndc | 62756-184-13 |
| ndc | 62756-184-18 |
| ndc | 62756-185-83 |
| ndc | 62756-185-88 |
| ndc | 62756-185-08 |
| ndc | 62756-185-13 |
| ndc | 62756-185-18 |
| code_info | Lot #: JKM7075A, Expiry:10/15 |
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-1081-2014%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.