⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

American Regent, Inc.: 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)10

DrugsSource: FDA (drug) · Date: 2026-08-26

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
American Regent, Inc.
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.
Reason / hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the U.S
Recall initiated
2026-07-24
Code info
Lot #: 25090, Exp. Date 2/28/2027.
Product quantity
41,680 vials
Voluntary mandated
Voluntary: Firm initiated
City
Shirley
State
NY
Country
United States
Event id
99503
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