Hypertension Tablets Recalled

The Harvard Drug Group, doing business as Major Pharmaceuticals and Rugby Laboratories, is recalling 3 lots of hydralazine hydrochloride tablets. According to the November 20, 2024, US Food and Drug Administration (FDA) Enforcement Report, samples from the lots failed to meet impurity and degradation specifications during routine stability testing.

The recall affects hydralazine hydrochloride tablets, 25 mg, packaged in 100-tablet cartons (NDC 0904-6441-61), from lots T04888 (Exp. 11/24), T04946 (Exp. 12/24), and T04970 (Exp. 7/25). The tablets were distributed by Avet Pharmaceuticals Inc., East Brunswick, New Jersey, and Major Pharmaceuticals, Livonia, Michigan, throughout the United States.

The Harvard Drug Group voluntarily initiated the recall on November 5, 2024. On November 14, 2024, the FDA designated the recall Class III, indicating that use of the affected drugs is not likely to cause harm.

Hydralazine is a prescription vasodilator used for the treatment of high blood pressure.