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Class IOngoing

American Regent, Inc. recalls 12 products

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
American Regent, Inc.
Reason
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
Nationwide within the U.S
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99503…

Products (12)

  1. 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, NY 11967.

    Codes/lots: Lot #: 24291, Exp. Date: 8/31/2026Quantity: 98,200 vialsRecall no. D-0791-2026Class II

  2. 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 only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

    Codes/lots: Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;Quantity: 235,350 vialsRecall no. D-0792-2026Class II

  3. 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 (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

    Codes/lots: Lot #: 25082, Exp. Date: 3/31/2027.Quantity: 26,450 vialsRecall no. D-0793-2026Class II

  4. 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 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.

    Codes/lots: Lot #: 24299, Exp. Date: 8/31/2026.Quantity: 63,200 vialsRecall no. D-0794-2026Class II

  5. 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 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.

    Codes/lots: Lot #: 24353, Exp. Date: 9/30/2026.Quantity: 89,775 vialsRecall no. D-0795-2026Class II

  6. 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, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

    Codes/lots: Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027Quantity: 316,450 vialsRecall no. D-0796-2026Class II

  7. 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, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

    Codes/lots: Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.Quantity: 169,200 vialsRecall no. D-0797-2026Class II

  8. 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.

    Codes/lots: Lot #: 25090, Exp. Date 2/28/2027.Quantity: 41,680 vialsRecall no. D-0798-2026Class II

  9. 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) Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

    Codes/lots: Lot #: 25163, Exp. Date: 4/30/2027.Quantity: 185,775 vialsRecall no. D-0799-2026Class II

  10. 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, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

    Codes/lots: Lot #: 25202, Exp. Date: 11/30/2026.Quantity: 86,100 vialsRecall no. D-0800-2026Class I

  11. 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, INC., SHIRLEY, NY 11967.

    Codes/lots: Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.Quantity: 323,000 vialsRecall no. D-0801-2026Class II

  12. 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), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.

    Codes/lots: Lot #: 25295N0C0, Exp. Date: 04/30/2027.Quantity: 43,460 vialsRecall no. D-0802-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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