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American Regent Recalls
8 recalls on record · May 29, 2024 to May 6, 2026 · Drugs
Recalls by year
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 6, 2026DrugsFDA
American Regent, Inc. recalls Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent
Hazard: Labeling: Missing Label
May 7, 2025DrugsFDA
American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc
Hazard: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
May 7, 2025DrugsFDA
American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc
Hazard: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
December 11, 2024DrugsFDA
American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In
Hazard: Presence of Particulate Matter: Potential for glass delamination from the vials.
December 11, 2024DrugsFDA
American Regent, Inc. recalls 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
Hazard: Presence of Particulate Matter: Potential for glass delamination from the vials.
December 11, 2024DrugsFDA
American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In
Hazard: Presence of Particulate Matter: Potential for glass delamination from the vials.
May 29, 2024DrugsFDA
American Regent, Inc. recalls Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous I
Hazard: Subpotent product in addition to having out-of-specification results for impurities.
May 29, 2024DrugsFDA
American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenou
Hazard: Lack of Assurance of Sterility.