American Regent is conducting a voluntary nationwide recall of one lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single-dose vials because of visible particulate matter identified as glass and/or paraformaldehyde.
The recall covers lot 25202, which was distributed nationwide in the United States beginning Sept. 30, 2025. The product has an expiration date of Nov. 30, 2026 and is identified under NDC 0517-4002-25.
American Regent said the presence of particulate matter in an injectable drug could cause local irritation or swelling. The company warned that particles could also travel through the bloodstream and block vessels in the heart, lungs or brain, potentially leading to stroke or death. Patients with underlying cardiovascular or pulmonary compromise may face a higher risk.
To date, the company said it has not received any reports of adverse events related to the recall.
Papaverine is a prescription medication that relaxes smooth muscle and widens blood vessels. It is primarily used to treat visceral spasms, poor blood circulation, and erectile dysfunction.
American Regent said Papaverine Hydrochloride Injection is a clear, colorless to pale-yellow solution supplied in a 2 mL single-dose vial containing 30 mg/mL. The company is notifying distributors and customers by letter and arranging for return or replacement of the recalled product.
The recall applies only to the single affected lot, according to the company.
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