FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent Selenious Acid Injection recalled for particulate contamination
What this means
American Regent's Selenious Acid Injection (a trace mineral used in intravenous nutrition) has been recalled because some vials contain particulate matter, including hair, glass, and/or paraformaldehyde. The contamination affects specific lot numbers distributed nationwide.
- Check your facility's inventory for lot #25090 (expires 2/28/2027).
- Do not use affected vials.
- Contact your supplier or American Regent for return and replacement instructions.
The agency's original wording
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Intended for
Adults (under 0 months)
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
41,680 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0798-2026More American Regent recalls
- FDA-Drug2026-09-16American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-PR2026-09-03American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-Drug2026-08-26American Regent Cyanocobalamin injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Tralement trace elements injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent aminocaproic acid injection recalled for particulate contamination
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