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CLASS II · ModerateFDA

SUN PHARMACEUTICAL INDUSTRIES INC recalls Carbamazepine Tablets

📅 Aug 3, 2026 · 📍 Nationwide
Recalling company
SUN PHARMACEUTICAL INDUSTRIES INC
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.
Reason
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 3, 2026
Reported
Aug 26, 2026
Distribution
US Nationwide.
Status
Ongoing
Quantity
1968 Bottles (1000Tablets/Bottle)
Lot / codes
Lot # AD94033, Exp Date: 5/31/2028.
Company location
Princeton, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0770-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0770-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.