FDA-Drug2026-08-26Class IIPROCESSING DEFECT
Sun Pharmaceutical Carbamazepine 200mg tablets recalled for manufacturing defect
What this means
Sun Pharmaceutical's Carbamazepine 200mg tablets (Lot #AD94033, expiring 5/31/2028) contain black spots caused by burnt ingredients during manufacturing. The tablets do not meet quality standards, though no injuries have been reported.
- Check if you have Carbamazepine tablets from Lot #AD94033 (expiring 5/31/2028).
- Do not stop taking your medication without talking to your doctor or pharmacist first.
- Contact your pharmacy or doctor for a replacement or alternative.
The agency's original wording
Hazard
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
1968 Bottles (1000Tablets/Bottle)
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0770-2026More Sun Pharmaceutical recalls
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