CLASS II Drug recall · Reported 19 Feb 2014 · FDA Enforcement Report
Oxcarbazepine Tablets, 300 mg recalled by Caraco Pharmaceutical
Caraco Pharmaceutical Laboratories is recalling Oxcarbazepine Tablets, 300 mg, distributed nationwide in the US. The recall was initiated on 29 Jan 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1081-2014
- FDA event ID
- 67426
- Recalling firm
- Caraco Pharmaceutical Laboratories, Cranbury, NJ
- Brand
- Oxcarbazepine
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jan 2014
- FDA classified
- 10 Feb 2014
- Reported
- 19 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Seizure Medication
Timeline
| 29 Jan 2014 | Recall initiated by company | |
| 10 Feb 2014 | Classified by FDA | +12 days |
| 19 Feb 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet Specifications: Broken Tablets Present.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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....
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet Specifications: Broken Tablets Present.
Which lots are affected?
Lot #: JKM7075A, Expiry:10/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Caraco Pharmaceutical Laboratories
All 12Other Oxcarbazepine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxcarbazepine Tablets 600mg recalled by Sun Pharmaceutical IndustriesOxcarbazepine | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS I | Oxcarbazepine Tablets, 300 mg per carton (10 recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | OXcarbazepine Tablet, 600 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |