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Class II · ModerateActive recall

Carbamazepine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # AD94033, Exp Date: 5/31/2028.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTaro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532 foreign manufacturer
Brand nameCARBAMAZEPINE
Generic nameCARBAMAZEPINE
Active ingredient(s)CARBAMAZEPINE
Distributed by / forTaro Pharmaceuticals USA, Inc., Hawthorne, NY 10532
NDC51672-4005-3
Show the full FDA record
Full product labelCarbamazepine 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.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionUS Nationwide.
Quantity1968 Bottles (1000Tablets/Bottle)
Recall initiated2026-08-03
Report date2026-08-26
Recall completed—
Recall numberD-0770-2026
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.