American Regent Recalls Papaverine Hydrochloride Injection Lot Due to Particulate Matter

American Regent, Inc. has initiated a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP, 60 mg/2 mL product. The recall is due to the identification of visible particulate matter, consisting of glass and/or paraformaldehyde, within the vials.

The presence of particulate matter in an injectable product could lead to local irritation or swelling. More seriously, these particles might travel and obstruct blood vessels in the lungs, heart, or brain, potentially causing stroke or even death. Patients with pre-existing cardiovascular or pulmonary conditions face a higher risk. American Regent has stated that it has not received any adverse event reports related to this recall to date.

The affected lot, number 25202, was distributed nationwide in the United States starting September 30, 2025. Papaverine Hydrochloride Injection is a prescription medication used to relax smooth muscles and widen blood vessels, typically administered intravenously under medical supervision.

American Regent is notifying its distributors and customers and arranging for the return or replacement of the recalled product. Wholesalers, retailers, and healthcare facilities are instructed to stop using the product and return it to the place of purchase or discard it. The company is undertaking this measure with the knowledge of the U.S. Food and Drug Administration to protect public health.