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Glenmark Issues Ziac Recall After Trace Ezetimibe Found in Tablets

Formal guidance for patients remains pending despite identification of affected lots.

Overview

  • Glenmark voluntarily recalled roughly 11,100 bottles of Ziac after reserve-sample testing detected trace amounts of the cholesterol drug ezetimibe.
  • The FDA classified the action as a Class III recall, indicating use is not likely to cause adverse health consequences.
  • The recall covers 2.5 mg and 6.25 mg tablets in 30-, 100-, and 500-count bottles with NDC 68462-878-30, 68462-878-01, and 68462-878-05.
  • Affected lots carry expiration dates from late 2025 into 2026, with specific codes listed in the recall notice.
  • Neither Glenmark nor the FDA has issued consumer instructions on disposal, returns, or replacement of the recalled bottles.