The contamination could block blood vessels and potentially cause stroke or death if injected. The recalled product was distributed across the United States beginning on Sept. 30, 2025.
American Regent Inc. announced on July 24 that it is recalling one lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single-dose vials to the consumer level after discovering particulate matter in the product. The U.S. Food and Drug Administration (FDA) published the company's recall notice on July 27.
The company said injecting medication containing particulate matter can cause local irritation or swelling. While more serious complications, such as stroke or death, can occur if particles travel through the bloodstream and block blood vessels in the heart, lungs, or brain.
American Regent said that patients who have underlying cardiovascular or pulmonary conditions face a greater risk of complications if they inject the medication.
“To date, American Regent, Inc. has not received any reports of adverse events related to this recall,” the company said.
The recalled injectable medication is a clear, colorless to pale-yellow solution in a 2 mL single-dose vial containing 30 milligrams per milliliter.
American Regent said it is notifying distributors and customers by letters and is arranging for the return or replacement of the recalled product.
Distributors, retailers, and healthcare facilities should stop using the affected lot and return it to the place of purchase or discard it. Patients using the recalled medication should stop using it and contact their physician or healthcare provider.
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” American Regent’s recall notice said.
Adverse events and quality concerns also can be reported to American Regent or through the FDA's MedWatch reporting program.
American Regent did not say how the glass or paraformaldehyde particles contaminated the affected lot, and the recall notice did not identify the source of the contamination.
NTD has reached out to American Regent for comment.