American Regent recalls
American Regent has 21 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 16 Sep 2026. 19 are still ongoing. 14 were reported in the last 12 months. The most frequent reason is particulate matter.
Total recalls 21 since 2024
Last 12 months 14 reported
Class I 2 10% of total
Ongoing 19 latest 16 Sep 2026
Recalls per month, last 24 months click a bar for that month Severity split
2 10%18 86%1 5%
Why american regent is recalled
Ongoing american regent recalls 19 active Reported Class Recall Company Reason Where 16 Sep 2026 Drug CLASS I Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalled Epinephrine American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Tralement (trace elements injection 4*, USP) recalled by American Regent Tralement American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalled Cyanocobalamin American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalled Selenious Acid American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American Regent Aminocaproic Acid American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II niCARdipine Hydrochloride Injection, USP, 25 mg/ (2.5 mg/mL) recalled Nicardipine Hydrochloride American Regent Particulate Matter Nationwide
All american regent recalls, newest first 21 total Reported Class Recall Company Reason Where 16 Sep 2026 Drug CLASS I Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalled Epinephrine American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Tralement (trace elements injection 4*, USP) recalled by American Regent Tralement American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalled Cyanocobalamin American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalled Selenious Acid American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American Regent Aminocaproic Acid American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II niCARdipine Hydrochloride Injection, USP, 25 mg/ (2.5 mg/mL) recalled Nicardipine Hydrochloride American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Nitroglycerin injection, USP, 50 mg/ (5 mg/mL) recalled Nitroglycerin American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Atropine Sulfate injection, USP, 1 mg/mL recalled by American Regent Atropine Sulfate American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Acetylcysteine Solution, USP, 10% (100 mg/mL) recalled Acetylcysteine American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS I Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalled Papaverine Hydrochloride American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Acetylcysteine Solution, USP, 20% (200 mg/mL) recalled Acetylcysteine American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Multrys (Trace Elements Injection 4, USP), For intravenous infusion recalled Multrys American Regent Particulate Matter Nationwide 26 Aug 2026 Drug CLASS II Cyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalled Cyanocobalamin American Regent Particulate Matter Nationwide 6 May 2026 Drug CLASS III Levocarnitine Injection, USP (200 mg/mL) Single-Dose Vial recalled Levocarnitine American Regent Labeling Errors Nationwide 7 May 2025 Drug CLASS II niCARdipine Hydrochloride Injection, USP, 25 mg recalled Nicardipine Hydrochloride American Regent Sterility Nationwide 7 May 2025 Drug CLASS II niCARdipine Hydrochloride Injection, USP, 25 mg recalled Nicardipine Hydrochloride American Regent Sterility Nationwide 11 Dec 2024 Drug CLASS II Venofer (iron sucrose) Injection recalled by American Regent Venofer American Regent Particulate Matter Nationwide 11 Dec 2024 Drug CLASS II Venofer (iron sucrose) Injection recalled by American Regent Venofer American Regent Particulate Matter Nationwide 11 Dec 2024 Drug CLASS II Venofer (iron sucrose) Injection recalled by American Regent Venofer American Regent Particulate Matter Nationwide 29 May 2024 Drug CLASS II niCARdipine Hydrochloride Injection, USP, 25 mg recalled Nicardipine Hydrochloride American Regent Sterility UT 29 May 2024 Drug CLASS II Vasopressin Injection, USP per mL) Multiple-Dose Vial recalled Vasopressin American Regent Potency & Assay Nationwide
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.