Recall Atlas

American Regent recalls

7 official recalls and safety alerts involving American Regent since 2024-05, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with American Regent or the relevant agency.

  1. 2026-09-16
  2. US
    Drugs & medicalClass I

    American Regent, Inc. recalls Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and…

    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.

    FDA · DrugAmerican Regent, Inc.Nationwide within the U.S.AOfficial notice →
  3. 2026-08-26
  4. US
    Drugs & medicalClass II

    American Regent, Inc. recalls 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…

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

    FDA · DrugAmerican Regent, Inc.Nationwide within the U.SOfficial notice →
  5. 2026-05-06
  6. US
    Drugs & medicalClass III

    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, Inc., Shirley,…

    Labeling: Missing Label

    FDA · DrugAmerican Regent, Inc.U.S. NationwideOfficial notice →
  7. 2025-05-07
  8. US
    Drugs & medicalClass II

    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., Lehi, UT…

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

    FDA · DrugAmerican Regent, Inc.Nationwide in the USAOfficial notice →
  9. 2024-12-11
  10. US
    Drugs & medicalClass II

    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 Intravenous Use…

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

    FDA · DrugAmerican Regent, Inc.Nationwide in the USAOfficial notice →
  11. 2024-05-29
  12. US
    Drugs & medicalClass II

    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 Infusion, American…

    Subpotent product in addition to having out-of-specification results for impurities.

    FDA · DrugAmerican Regent, Inc.USA NationwideOfficial notice →
  13. US
    Drugs & medicalClass II

    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 Intravenous Use Only, Mfd…

    Lack of Assurance of Sterility.

    FDA · DrugAmerican Regent, Inc.UT onlyOfficial notice →