Why it was recalled
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # AD94033, Exp Date: 5/31/2028.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0770-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 3, 2026
- FDA report date
- Aug 26, 2026
- Quantity
- 1968 Bottles (1000Tablets/Bottle)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0770-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99562
- Address
- 2 Independence Way
- Code information
- Lot # AD94033, Exp Date: 5/31/2028.
- Postal code
- 08540-6620
- Report date
- Aug 26, 2026
- Product type
- Drugs
- Recall number
- D-0770-2026
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 1968 Bottles (1000Tablets/Bottle)
- Reason for recall
- CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Aug 3, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2026