American Regent recalls
FDA enforcement reports naming American Regent, Inc. as the recalling firm.
- Recall reports
- 21
- Class I (serious)
- 2
- Most recent report
- Sep 16, 2026
- Sep 16, 2026Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, Fo…Drug · American Regent, Inc.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.Class I
- Aug 26, 2026Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in…Drug · American Regent, Inc.Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehydeClass II
- Aug 26, 2026AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE…Drug · American Regent, Inc.Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehydeClass II
- Aug 26, 2026niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2Drug · American Regent, Inc.Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehydeClass II
- Aug 26, 2026ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTI…Drug · American Regent, Inc.Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehydeClass II
- Aug 26, 2026ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTI…Drug · American Regent, Inc.Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehydeClass II
- Aug 26, 2026Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 05…Drug · American Regent, Inc.Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehydeClass II
- Aug 26, 2026Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 m…Drug · American Regent, Inc.Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehydeClass II
- Aug 26, 2026Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vi…Drug · American Regent, Inc.Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehydeClass I
- Aug 26, 2026Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC…Drug · American Regent, Inc.Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehydeClass II
- Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, p…
- Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL…
- Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a)…
- Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intraven…
- niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2
- niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2
- Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL S…
- Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2
- Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL S…
- Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose…
- niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2
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