American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate Matter
July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass and/or paraformaldehyde.
Risk Statement: The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Patients with underlying cardiovascular or pulmonary compromise may be at increased risk. To date, American Regent, Inc. has not received any reports of adverse events related to this recall.