American Regent, Inc. recalls Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x
Recalled August 26, 2026 · FDA recall D-0800-2026 · American Regent
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde · FDA Class I
Units
86,100 vials
Sold at
Nationwide within the U.S
Description
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Product
Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Manufacturer(s)
American Regent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →