October 29, 2020
Mylan Pharmaceuticals Inc. is recalling more than 10,000 bottles of candesartan cilexetil and hydrochlorothiazide tablets, 32 mg/12.5 mg, after routine stability testing of two lots yielded out-of-specification organic impurity results. The recall was included in the October 28, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 90-count bottles (NDC 0378-3002-77) from lot 8095666 (Exp. 7/21) and 500-count bottles (NDC 0378-3002-05) from lot 3104664 (Exp. 7/21). The affected tablets were distributed within the United States.
Mylan Pharmaceuticals initiated the voluntary recall October 2, 2020. The FDA designated the recall Class III on October 22, 2020, suggesting use of the recalled tablets is not likely to cause harm.
Candesartan is a prescription angiotensin II receptor blocker used to treat high blood pressure and heart failure.