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

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Other recalls by Caraco Pharmaceutical Laboratories

• Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only,…
  FDA Drug · Class II · 2014-08-13 · Caraco Pharmaceutical Laboratories
• Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only,…
  FDA Drug · Class II · 2014-08-13 · Caraco Pharmaceutical Laboratories
• Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles
  FDA Drug · Class II · 2014-07-09 · Caraco Pharmaceutical Laboratories
• Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmac…
  FDA Drug · Class II · 2014-07-02 · Caraco Pharmaceutical Laboratories
• Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5)
  FDA Drug · Class II · 2014-05-07 · Caraco Pharmaceutical Laboratories

All Caraco Pharmaceutical Laboratories recalls

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.