American Regent Issues Nationwide Recall of Papaverine Hydrochloride Injection Due to Glass and Paraformaldehyde Particulate Contamination
Key Insights
American Regent, Inc. has issued a voluntary nationwide recall of one lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL due to the presence of glass and/or paraformaldehyde particulate matter.
The contaminated particulate matter could travel through blood vessels and block vessels in the heart, lungs, or brain, potentially causing stroke (search) or death.
Lot #25202 was distributed nationwide beginning September 30, 2025, with an expiration date of November 30, 2026, and no adverse events have been reported to date.
American Regent, Inc., based in Shirley, New York, announced on July 24, 2026, a voluntary nationwide recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single-dose vial. The recall, conducted with the knowledge of the U.S. Food and Drug Administration, was initiated after the discovery of visible particulate matter identified as glass and/or paraformaldehyde in the product.
The affected lot, Lot #25202 (NDC: 0517-4002-25), carries an expiration date of November 30, 2026, and was distributed nationwide across the United States beginning September 30, 2025.
Clinical Risks Associated with Particulate Contamination
The administration of an injectable product containing particulate matter poses significant safety risks. According to the company's risk statement, particulate matter may result in local irritation or swelling at the injection site. More critically, the particulate matter could travel through and block blood vessels in the heart, lungs, or brain, which can cause stroke (search) and even lead to death. Patients with underlying cardiovascular or pulmonary compromise may be at increased risk for these adverse outcomes.
To date, American Regent, Inc. has not received any reports of adverse events related to this recall.
Product Indications and Characteristics
Papaverine is a prescription medication that relaxes smooth muscles and widens blood vessels. It is primarily used to treat visceral spasms (search), poor blood circulation, and erectile dysfunction (search). Papaverine Hydrochloride Injection, USP, is a clear, colorless to pale-yellow solution supplied in a 2 mL single-dose vial containing 30 mg/mL. The product is administered as an intravenous injection and is intended for use by or under the direction of a physician.
Recall Actions and Recommendations
American Regent, Inc. is notifying its distributors and customers by letter and is arranging for the return or replacement of all recalled products. Distributors, retailers, and healthcare facilities that have the recalled product in their possession should immediately stop using it and either return it to the place of purchase or discard the product.
Patients currently using this product are advised to stop use and contact their physician or healthcare provider. Consumers who have experienced any problems that may be related to the use of this drug product should contact their physician or healthcare provider promptly.
Adverse Event Reporting
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, by regular mail, or by fax at 1-800-FDA-0178.
American Regent, Inc. stated that it is committed to the safety of patients who rely on its products and is taking this precautionary action to protect public health. Consumers and healthcare professionals with questions regarding this recall can contact American Regent, Inc. Customer Service at 1-800-645-1706.