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American Regent, Inc. recalls Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 051

Recalled August 26, 2026 · FDA recall D-0798-2026 · American Regent

Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde · FDA Class II
Units
41,680 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
Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), 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

American Regent, Inc. recalls Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 051 | RecallWatchUSA