Blood Pressure Drug Recalled for Impurities

Amerisource Health Services is recalling a single lot of hydralazine hydrochloride tablets for failing to meet impurity specifications. The October 11, 2023, US Food and Drug Administration (FDA) Enforcement Report cited “out-of-specification results in the repackaged product for impurities at the 12-month time point.”

The recall affects hydralazine hydrochloride tablets, 10 mg, 100 tablets per carton (individual dose NDC 68084-447-11, carton NDC 68084-447-01), from lot 1007002 (Exp. 12/31/23). The tablets were distributed by American Health Packaging, Columbus, Ohio, throughout the US.

Amerisource Health Services voluntarily initiated the recall September 1, 2023. The FDA designated the recall Class III on October 5, 2023. Per the Class III designation, use of the affected tablets is not likely to cause harm.

Hydralazine is a prescription vasodilator used alone or as an adjunct to treat patients with essential hypertension.