Carbamazepine Tablets recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIOngoing
Summary: SUN PHARMACEUTICAL INDUSTRIES INC is recalling 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.
What is being recalled
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.
Why
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot # AD94033, Exp Date: 5/31/2028.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0770-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 3, 2026 |
| Reported | August 26, 2026 |
| Company | SUN PHARMACEUTICAL INDUSTRIES INC |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1968 Bottles (1000Tablets/Bottle) |
More recalls from SUN PHARMACEUTICAL INDUSTRIES INC · all drug recalls · recalls from August 2026