Oxcarbazepine Tablets — Class II drug recall D-1081-2014
Terminated recall by Caraco Pharmaceutical Laboratories Ltd., reported 2014-02-19, distributed nationwide. Failed Tablet Specifications: Broken Tablets Present.
| Recall number | D-1081-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caraco Pharmaceutical Laboratories Ltd., Cranbury, NJ, United States |
| Recall initiated | 2014-01-29 |
| Classified | 2014-02-10 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 7,005 bottles |
| NDC | 62756-0183, 62756-0183-08, 62756-0183-13, 62756-0183-18, 62756-0183-83, 62756-0183-88, 62756-0184, 62756-0184-08, 62756-0184-13, 62756-0184-18, 62756-0184-83, 62756-0184-88, 62756-0185, 62756-0185-08, 62756-0185-13, 62756-0185-18, 62756-0185-83, 62756-0185-88 |
| Lot numbers | 10/15, JKM7075A |
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 for recall
Failed Tablet Specifications: Broken Tablets Present.
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-1081-2014. 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.