D-0770-2026 Class II Ongoing
FDA drug recall D-0770-2026 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on August 3, 2026 and is designated Class II. Reason for recall: CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing The recall status is ongoing. Affected quantity: 1968 Bottles (1000Tablets/Bottle).
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2026
- Initiation Date
- August 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1968 Bottles (1000Tablets/Bottle)
Product Description
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
Reason for Recall
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Distribution Pattern
US Nationwide.
Code Information
Lot # AD94033, Exp Date: 5/31/2028.