Home / Brand archive

American Regent, Inc. recall records

19 reported ongoing

23 records in this archive. Latest source date Sep 3, 2026. 2 published notices do not supply a closure status.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Sep 3, 2026FDA company announcement

American Regent, Inc.: Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Not suppliedPublished notice; closure not supplied

Distribution: Not supplied

Official source

Aug 11, 2026FDA drug enforcement

Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY,...

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.

Class IReported ongoing

Distribution: Nationwide within the U.S.A

Official source

Jul 27, 2026FDA company announcement

American Regent, Inc.: Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL

Products were found to contain particulate matter

Not suppliedPublished notice; closure not supplied

Distribution: Not supplied

Official source

Jul 24, 2026FDA drug enforcement

Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, ...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx ...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (N...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 05...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

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 0517-1001-2...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only,...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only,...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

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-...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25)...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERIC...

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

Class IReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Jul 24, 2026FDA drug enforcement

niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), ...

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

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Apr 16, 2026FDA drug enforcement

Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01

Labeling: Missing Label

Class IIIReported ongoing

Distribution: U.S. Nationwide

Official source

Apr 18, 2025FDA drug enforcement

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Alba...

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Apr 18, 2025FDA drug enforcement

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial...

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Nov 11, 2024FDA drug enforcement

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Car...

Presence of Particulate Matter: Potential for glass delamination from the vials.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Nov 11, 2024FDA drug enforcement

Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical ...

Presence of Particulate Matter: Potential for glass delamination from the vials.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Reasons in these listed records

Presence of particulate matter and lack of sterility assurance
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Products were found to contain particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

These examples come from this result page and are not a ranking of every recall reason.

Checking American Regent, Inc.

Is there a recall on american regent, inc. right now?

This archive contains 23 records, including 19 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking