Sun Pharma Recalls 1,968 Bottles of Epilepsy Drug Carbamazepine in US
New Delhi: Sun Pharmaceutical Industries Inc. has initiated a voluntary, firm-initiated recall of 1,968 bottles of Carbamazepine Tablets, USP, 200 mg, in the US after black spots were found on the tablets due to burnt excipient during manufacturing, according to an updated US Food and Drug Administration (USFDA) enforcement report.
Carbamazepine is an anticonvulsant medicine commonly used in the treatment of epilepsy and certain seizure disorders, among other indications.
The recall has been classified as a Class II recall and remains ongoing. The affected product was distributed nationwide across the United States.
The recalled product is Carbamazepine Tablets, USP, 200 mg, 1,000-count bottles, Rx only, bearing NDC 51672-4005-3. The tablets were manufactured by Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel, and distributed by Taro Pharmaceuticals USA Inc., Hawthorne, New York.
The affected product is from Lot No. AD94033, with an expiration date of May 31, 2028. A total of 1,968 bottles, each containing 1,000 tablets, are covered by the recall.
The recall is listed under Recall No. D-0770-2026, with Event ID 99562. The recall was initiated on August 3, 2026, and the termination date is listed as not applicable. The initial notification was issued to consignees through a letter.
According to the enforcement report, the reason for the recall was updated on August 19, 2026. The earlier reason cited a complaint regarding tablets with black specks. The updated reason states: "CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing."
The recalling firm, Sun Pharmaceutical Industries Inc., is based at 2 Independence Way, Princeton, New Jersey.
The recall remains classified as ongoing and applies to the US nationwide distribution network.
