The Recall Desk

Manufacturer

American Regent, Inc.

20 recalls in our database name American Regent, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
20
Critical
1
Severe
13
Most recent
2026-08-26

Of the 20 recalls from American Regent, Inc. we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 13 (65%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–20 of 20

  • SevereFDA (Drugs)·D-0791-2026·2026-08-26

    American Regent Recalls Nitroglycerin Injection Due to Particulate Matter

    American Regent, Inc. is recalling Nitroglycerin injection vials due to the presence of particulate matter, including hair, glass, and paraformaldehyde.

    Product
    NITROGLYCERIN — NITROGLYCERIN (NITROGLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0802-2026·2026-08-26

    FDA Recalls Nicardipine Hydrochloride Injection Due to Particulate Matter

    American Regent, Inc. is recalling 43,460 vials of Nicardipine Hydrochloride Injection due to the presence of particulate matter, including hair, glass, and paraformaldehyde.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0793-2026·2026-08-26

    American Regent Recalls Cyanocobalamin Injections Due to Particulate Matter

    American Regent, Inc. is recalling specific lots of Cyanocobalamin injections due to the presence of particulate matter, including hair, glass, and paraformaldehyde.

    Product
    CYANOCOBALAMIN — CYANOCOBALAMIN (CYANOCOBALAMIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0795-2026·2026-08-26

    American Regent Recalls Atropine Sulfate Injection Due to Particulate Matter

    American Regent, Inc. is recalling Atropine Sulfate injection vials because they contain particulate matter, including hair, glass, and paraformaldehyde.

    Product
    ATROPINE SULFATE — ATROPINE SULFATE (ATROPINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0796-2026·2026-08-26

    American Regent Recalls Acetylcysteine Solution Due to Particulate Matter

    American Regent, Inc. is recalling specific lots of Acetylcysteine Solution, USP, 10% due to the presence of particulate matter, including hair, glass, and paraformaldehyde.

    Product
    ACETYLCYSTEINE — ACETYLCYSTEINE (ACETYLCYSTEINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0797-2026·2026-08-26

    American Regent Recalls Acetylcysteine Solution Due to Particulate Matter

    American Regent, Inc. is recalling Acetylcysteine Solution USP due to the presence of particulate matter, including hair, glass, and paraformaldehyde.

    Product
    ACETYLCYSTEINE — ACETYLCYSTEINE (ACETYLCYSTEINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0794-2026·2026-08-26

    Aminocaproic Acid Injection Recalled for Particulate Matter Contamination

    American Regent, Inc. is recalling Aminocaproic Acid Injection due to the presence of particulate matter, including hair, glass, and paraformaldehyde.

    Product
    AMINOCAPROIC ACID — AMINOCAPROIC ACID (AMINOCAPROIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0801-2026·2026-08-26

    American Regent Recalls Tralement Injection Due to Particulate Matter

    American Regent is recalling 323,000 vials of Tralement (trace elements injection 4) due to the presence of particulate matter, including hair, glass, and paraformaldehyde.

    Product
    TRALEMENT — TRALEMENT (TRACE ELEMENTS INJECTION 4)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0494-2026·2026-05-06

    Levocarnitine Injection USP Missing Label Recall

    American Regent, Inc. is recalling Levocarnitine Injection USP (1 g/5 mL) due to missing labeling on certain lots. The affected product was distributed nationwide.

    Product
    LEVOCARNITINE — LEVOCARNITINE (LEVOCARNITINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2025·2025-05-07

    Nicardipine Hydrochloride Injection Recalled for Potential Sterility Loss

    American Regent, Inc. is recalling certain lots of Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects 7,249 cartons distributed nationwide.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2025·2025-05-07

    Nicardipine Hydrochloride Injection Recalled for Potential Sterility Issues

    American Regent, Inc. is recalling Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects multiple lots distributed nationwide.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0080-2025·2024-12-11

    Venofer Iron Sucrose Injection Recalled for Potential Glass Contamination

    American Regent is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination from vials. The affected drug is distributed nationwide.

    Product
    VENOFER — VENOFER (IRON SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0081-2025·2024-12-11

    Iron sucrose injection recall due to potential glass contamination in vials

    VENOFER (iron sucrose) injection is being recalled nationwide because certain vials may contain glass particles from potential glass delamination. Patients and healthcare providers should contact their pharmacist or healthcare provider immediately.

    Product
    VENOFER — VENOFER (IRON SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0082-2025·2024-12-11

    Prescription Drug Recall: Venofer Iron Sucrose Vials with Glass Delamination Risk

    American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.

    Product
    VENOFER — VENOFER (IRON SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2024·2024-05-29

    Nicardipine Hydrochloride Injection Recalled for Sterility Assurance Concerns

    American Regent, Inc. is recalling Nicardipine Hydrochloride Injection (25 mg/10 mL) in one lot due to lack of assurance of sterility. The recall affects approximately 4,136 cartons distributed in Utah.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

American Regent

medical product supply company

Country
United States

Official website

Source: Wikidata (Q113558863), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.