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The U.S. Food and Drug Administration (FDA) has confirmed the recall of 57,504 bottles of pitavastatin, a statin drug commonly prescribed to lower cholesterol and reduce the risk of heart disease.

The voluntary recall, initiated by Taiwan-based Orient Pharma Co. for Teva Pharmaceuticals, was due to the drug failing to meet quality standards for impurities and degradation. Each recalled bottle contained 90 tablets of the 2-milligram dose.

The FDA classified the action as a Class III recall, meaning the product violates regulations but is not likely to cause serious health risks. No adverse effects have been reported so far.

Pitavastatin, marketed under brand names like Livalo and Zypitama, works by lowering LDL (“bad” cholesterol) and raising HDL (“good” cholesterol). Statins remain one of the most widely prescribed drug classes in the U.S., with over 90 million Americans taking them.

This recall follows other recent statin-related recalls, including atorvastatin and additional batches of Livalo earlier this year, highlighting ongoing concerns about drug quality control.