science
Nearly 1 Million Bottles of Heart Failure Drug Recalled
A nationwide recall covers 934,577 bottles of Corlanor after the manufacturer reported possible foreign substance contamination. The FDA classified the action as Class II, indicating temporary or reversible health risks.
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A medication used to treat heart failure is being recalled across the United States after the manufacturer reported that some bottles may contain a foreign substance. The recall covers at least 934,577 bottles of Corlanor, the brand name for ivabradine 5 mg tablets. The tablets were manufactured in Italy.
The company initiated the recall on June 4.
The FDA later classified it as a Class II recall, meaning use or exposure may cause temporary or reversible adverse health effects. Corlanor is prescribed to adults with chronic heart failure to reduce the risk of hospitalization. It is also approved for children aged 6 months and older who have stable heart failure caused by an enlarged heart.
The FDA posted an updated enforcement report with additional information about the recall.
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