Class IIDrug
Carbamazepine Tablets recall
Summary
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Carbamazepine Tablets (drug). According to the FDA report, the reason is: CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Lot / code info
- Lot # AD94033, Exp Date: 5/31/2028.
- Quantity
- 1968 Bottles (1000Tablets/Bottle)
- Distribution
- US Nationwide.
- Recalling company
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ United States
- Recall started
- August 3, 2026
- FDA report date
- August 26, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0770-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (SUN PHARMACEUTICAL INDUSTRIES INC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.