Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd.,…

Sun Pharmaceutical Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only
  • Manufactured byTaro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
  • Distributed byTaro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3
Lot codes and dates
  • Lot # AD94033
  • Exp Date5/31/2028
Amount recalled
1968 Bottles (1000Tablets/Bottle)

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Notice updated Aug 19, 2026 · Data as of Sep 19, 5:37 PM UTC

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