Mylan Pharmaceuticals is recalling approximately 10,695 bottles of Candesartan Cilexetil and Hydrochlorothiazide Tablets (32 mg/12.5 mg), a prescription medication used to treat high blood pressure. The recall was issued because routine stability testing found levels of an organic impurity that exceeded approved safety specifications. This recall affects both 90-count and 500-count bottles that were distributed nationwide throughout the United States. Consumers should consult their doctor or pharmacist before stopping this medication, as the risks of stopping blood pressure treatment may outweigh the risks of the impurity.
The product contains organic impurities at levels higher than safety standards allow, which could lead to health complications over long periods of use. No specific injuries or adverse events have been reported at the time of this recall.
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Sources: FDA iRES · Raw API Response
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