FDA Issues Class II Recall for Nicardipine Hydrochloride Injection Due to Sterility Concerns

The US Food and Drug Administration (FDA) has announced a Class II recall of Nicardipine Hydrochloride Injection, USP (25 mg/10 mL), distributed under 2 product labels by Civica, Inc. and American Regent, Inc. The recall was initiated after product leakage was observed around the vial neck, raising concerns over sterility assurance. The recall affects a total of over 37 000 cartons (each containing 10 single-dose vials), with impacted lots expiring between June 2025 and June 2026. The voluntary recall began on April 18, 2025, and the product was distributed nationwide in the United States.

The recalling firm, American Regent, Inc., based in New Albany, Ohio, notified its consignees by letter. The FDA classified this recall as Class II on May 1, 2025, indicating that use of the product may cause temporary or medically reversible adverse health consequences, with a low probability of serious health effects. While no public press release has been issued, pharmacists are advised to review inventory for affected Civica-labeled (NDC 72572-470) and American Regent-labeled (NDC 0517-0735) vials and remove them from distribution immediately.

Nicardipine hydrochloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension, particularly when oral therapy is not feasible or desired, such as in perioperative or critical care settings. A lack of sterility may lead to serious infections, particularly in patients receiving intravenous therapy in hospital environments.