MedicineWatch US

American Regent, Inc. Provisional

New Albany, OH · united states

20 recall flag(s), 1 Class I

FDA Flags (20)

Class II RecallAug 2026
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 Vi
Classification: Class II
Class II RecallAug 2026
American Regent, Inc.
Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302
Classification: Class II
Class II RecallAug 2026
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) 25x
Classification: Class II
Class I RecallAug 2026
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) 25x
Classification: Class I
Class II RecallAug 2026
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) 25x
Classification: Class II
Class II RecallAug 2026
American Regent, Inc.
Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1
Classification: Class II
Class II RecallAug 2026
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 (ND
Classification: Class II
Class II RecallAug 2026
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-0
Classification: Class II
Class II RecallAug 2026
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 0
Classification: Class II
Class II RecallAug 2026
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 051
Classification: Class II
Class II RecallAug 2026
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
Classification: Class II
Class II RecallAug 2026
American Regent, Inc.
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Singl
Classification: Class II
Class III RecallMay 2026
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
Classification: Class III
Class II RecallMay 2025
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc
Classification: Class II
Class II RecallMay 2025
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc
Classification: Class II
Class II RecallDec 2024
American Regent, Inc.
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In
Classification: Class II
Class II RecallDec 2024
American Regent, Inc.
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
Classification: Class II
Class II RecallDec 2024
American Regent, Inc.
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In
Classification: Class II
Class II RecallMay 2024
American Regent, Inc.
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous I
Classification: Class II
Class II RecallMay 2024
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenou
Classification: Class II