Capsules Recalled for Unknown Impurity

Amneal Pharmaceuticals of New York is recalling 858 bottles of phenoxybenzamine hydrochloride capsules because they are out of specification for an unknown impurity, according to the February 14, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects phenoxybenzamine hydrochloride capsules, 10 mg, in 100-count bottles (NDC 60219-1502-01), from lots AM221153 (Exp. 6/30/24) and AM230497 (Exp. 2/29/25). The capsules were manufactured by Amneal Pharmaceuticals Pvt. Ltd, Ahmedabad, India, and distributed by Amneal Pharmaceuticals, Bridgewater, New Jersey, throughout the United States.

Amneal Pharmaceuticals of New York voluntarily initiated the recall January 15, 2024. On February 8, 2024, the FDA designated it Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Phenoxybenzamine hydrochloride capsules are a prescription drug indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating.