American Regent, Inc.: 21 recalls on record

Recalls filed with 1 agency: FDA (21).

First recall on record: May 29, 2024. Most recent: September 16, 2026.

Risk classification: Class I: 2 · Class II: 18 · Class III: 1

Most recent recalls

DateAgencyProduct
September 16, 2026FDAEpinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For …D-0865-2026
August 26, 2026FDASelenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a…D-0798-2026
August 26, 2026FDAMultrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL …D-0799-2026
August 26, 2026FDAAtropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 …D-0795-2026
August 26, 2026FDAACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION…D-0797-2026
August 26, 2026FDAniCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Si…D-0802-2026
August 26, 2026FDATralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0…D-0801-2026
August 26, 2026FDAAMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE D…D-0794-2026
August 26, 2026FDACyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, pac…D-0793-2026
August 26, 2026FDAACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION…D-0796-2026
August 26, 2026FDANitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517…D-0791-2026
August 26, 2026FDAPapaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial…D-0800-2026
August 26, 2026FDACyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Mu…D-0792-2026
May 6, 2026FDALevocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenou…D-0494-2026
May 7, 2025FDAniCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial…D-0398-2025
May 7, 2025FDAniCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial…D-0399-2025
December 11, 2024FDAVenofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Sin…D-0080-2025
December 11, 2024FDAVenofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL …D-0081-2025
December 11, 2024FDAVenofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Sin…D-0082-2025
May 29, 2024FDAVasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vi…D-0507-2024
May 29, 2024FDAniCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose…D-0503-2024

Questions about this company

How many recalls does American Regent, Inc. have?
Recalert has 21 U.S. recalls on record for American Regent, Inc., published between May 29, 2024 and September 16, 2026.
What was the most recent American Regent, Inc. recall?
FDA recall D-0865-2026, published September 16, 2026: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-30…
Which agencies have handled American Regent, Inc. recalls?
American Regent, Inc. appears as the recalling firm in recalls from: FDA (21).

Do you carry products from American Regent, Inc.? Check your whole catalog free against 80,000+ recalls.

Paste up to 100 UPCs or SKUs and see which ones match a CPSC, FDA, NHTSA or FSIS recall. No account needed.

Check my catalog free

Want it checked every night instead? Starter watches 500 SKUs for $29/month. See plans

Related companies