Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026

Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC…

American Regent, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: American Regent, Inc. · 5 Ramsay Rd · Shirley, NY · 11967-4701

Is this the product you have?

  • 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.
Lot codes and dates
    • Lot #: 25090
    • Exp. Date 2/28/2027
Amount recalled
41,680 vials

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Notice updated Aug 26, 2026 · Data as of Sep 19, 3:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.