FDA Drugs recall ·
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only… recall
- Recall number
- D-0770-2026
- Date
- (initiated August 3, 2026)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1968 Bottles (1000Tablets/Bottle)
- Hazard tags
- Manufacturing practices (cGMP) Burn
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # AD94033, Exp Date: 5/31/2028.
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0770-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.