Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Oxcarbazepine Tablets Recalled by Caraco Pharmaceutical Laboratories Ltd. Due to Failed Tablet Specifications: Broken Tablets Present.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Caraco Pharmaceutical Laboratories Ltd. directly.
Affected Products
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....
Quantity: 7005 bottles
Why Was This Recalled?
Failed Tablet Specifications: Broken Tablets Present.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Caraco Pharmaceutical Laboratories Ltd.
Caraco Pharmaceutical Laboratories Ltd. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report