American Regent, Inc. recalls Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1
Recalled August 26, 2026 · FDA recall D-0795-2026 · American Regent
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde · FDA Class II
Units
89,775 vials
Sold at
Nationwide within the U.S
Description
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Product
Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), 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 →