Hypertension Drug Recalled

A single lot of hydralazine hydrochloride tablets distributed by Major Pharmaceuticals is under recall following an out-of-specification result obtained during routine stability testing for impurities. The recall appeared in the February 21, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects a total 8198 units of hydralazine hydrochloride tablets, 10 mg, packaged in 100-count (10 x 10 blister cards, NDC 0904-6440-61), from lot T04680 (Exp. 6/24). The tablets were manufactured for Heritage Pharmaceuticals Inc., Eatontown, New Jersey, and were distributed throughout the United States by Major Pharmaceuticals, Livonia, Michigan.

The Harvard Drug Group, which does business as Major Pharmaceuticals and Rugby Laboratories, voluntarily initiated the recall February 9, 2024. On February 13, 2024, the FDA designated the recall Class II, communicating that use of the affected drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Hydralazine hydrochloride is a prescription vasodilator indicated for the treatment of essential hypertension.