← Every firm
American Regent, Inc. FDA Recalls
21 recalls on file across drugs, 2 of them Class I and 19 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscClass IAug 11, 2026Presence of Particulate Matter and Lack of Assurance of Ster |
| Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302Class IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25xClass IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25xClass IJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01Class IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 051Class IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25xClass IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-0Class IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1Class IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL SinglClass IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDClass IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0Class IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| 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 ViClass IIJul 24, 2026Presence of Particulate Matter: Product contaminated with pa |
| Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American RegentClass IIIApr 16, 2026Labeling: Missing Label |
| niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, IncClass IIApr 18, 2025Lack of sterility assurance: Product leakage around the vial |
| niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, IncClass IIApr 18, 2025Lack of sterility assurance: Product leakage around the vial |
| Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For InClass IINov 11, 2024Presence of Particulate Matter: Potential for glass delamina |
| Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, ForClass IINov 11, 2024Presence of Particulate Matter: Potential for glass delamina |
| Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For InClass IINov 11, 2024Presence of Particulate Matter: Potential for glass delamina |
| niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For IntravenouClass IIMay 14, 2024Lack of Assurance of Sterility. |
| Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous IClass IIMay 13, 2024Subpotent product in addition to having out-of-specification |