FDAFDA recall D-0770-2026 · Aug 26, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Carbamazepine Tablets recall
Recall found
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 for recall
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot # AD94033, Exp Date: 5/31/2028.
- Quantity
- 1968 Bottles (1000Tablets/Bottle)
- Distribution
- US Nationwide.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-03
Source: openFDA enforcement record D-0770-2026 · search recall number D-0770-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.