FDA recall, , Moderate risk
Taro Carbamazepine Tablets
Carbamazepine tablets may contain black specks from burnt excipient during manufacturing.
Summary by Recall Canary from the FDA notice
What happened
SUN PHARMACEUTICAL INDUSTRIES INC, of Princeton, New Jersey, recalled Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, distributed by Taro Pharmaceuticals USA, Inc., after a complaint report regarding tablets with black specks. The black spots were found on tablets from burnt excipient during manufacturing, a CGMP deviation. The recall began August 3, 2026, and was added to the FDA's Enforcement Report on August 18, 2026.
The recalled product was distributed nationwide in the United States. The tablets are manufactured by Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel. The recall covers 1968 bottles, each containing 1000 tablets.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Carbamazepine Tablets, USP, 200mg, 1000 count bottles
- NDC
- 51672-4005-3
- Lot code
- AD94033
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Quality problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99562
- Recall number
- D-0770-2026
- Quantity recalled
- 1968 Bottles (1000Tablets/Bottle)
All recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
