Hypertension Drug Recalled

Sun Pharmaceutical Industries Inc is recalling more than 30,000 bottles of diltiazem hydrochloride extended-release capsules because samples failed to meet impurity and dissolution specifications during testing, according to the February 8, 2023, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects diltiazem hydrochloride extended-release capsules, 360 mg, 90-count bottles (NDC 47335-679-81), from lots HAC3120A and HAC3121A (Exp. 4/23), HAC4460A (Exp. 10/23), HAD0365A (Exp. 12/23), and HAD1452A (Exp. 2/24). The capsules were manufactured by Sun Pharmaceutical Industries Ltd, Gujarat, India, and distributed by Sun Pharmaceutical Industries Inc, Cranbury, New Jersey, throughout the United States.

Sun Pharmaceutical Industries voluntarily initiated the recall January 13, 2023. The FDA designated the recall Class II on February 2, 2023, signaling use of the product could cause temporary or medically reversible adverse health consequences, and a remote possibility of serious harm also exists.

Diltiazem hydrochloride extended-release capsules are a prescription calcium-channel blocker used to treat high blood pressure and manage chest pain.