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FDAFDA · Food and drugs·Recall number D-0770-2026

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.

Published August 26, 2026 · Recall initiated: August 3, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
CARBAMAZEPINE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Distributor
US Nationwide.
UPC
0351672405014
Lot
Lot # AD94033, Exp Date: 5/31/2028.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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