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American Regent recalls - full list & free alerts

14 official U.S. recalls involving American Regent in the last 12 months, most recently on 2026-09-16.

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Full list (14)

American Regent, Inc.: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneou
DrugsFDA (drug) · 2026-09-16 · Class I
American Regent, Inc.: 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 o
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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 Mu
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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 I
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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 I
DrugsFDA (drug) · 2026-08-26 · Class II
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
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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 Vial
DrugsFDA (drug) · 2026-08-26 · Class I
American Regent, Inc.: Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 05
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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 S
DrugsFDA (drug) · 2026-08-26 · Class II
American Regent, Inc.: 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
DrugsFDA (drug) · 2026-05-06 · Class III