August 2026 FDA Recall Carbamazepine by Sun Pharmaceutical Industries Inc
D-0770-2026 - CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on August 3, 2026 for the product Carbamazepine. The FDA reported the reason for recall as cgmp deviations; black spots found on tablets from burnt excipient during manufacturing. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0770-2026
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
08-03-2026
08-26-2026
1968 Bottles (1000Tablets/Bottle)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# AD94033, Exp Date: 5/31/2028.
