AMERICAN REGENT, INC.

American Regent Issues Nationwide Recall of Papaverine Hydrochloride Injection Due to Glass and Paraformaldehyde Particulate Contamination

- 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 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. - Healthcare facilities and consumers are instructed to stop using the recalled product immediately and return it to the place of purchase or discard it.