Quick answers
- What is Ferumoxytol used for?
- The FDA-approved label (FeraBright, Azurity Pharmaceuticals, Inc., October 14, 2025) says: “FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ferumoxytol have a boxed warning?
- Yes. The FDA label for FeraBright has a boxed warning (“WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ferumoxytol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ferumoxytol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ferumoxytol?
- 1 company lists prescription products of Ferumoxytol in the FDA NDC Directory, including Azurity Pharmaceuticals, Inc..
What Ferumoxytol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. …
— FDA label: FeraBright, Azurity Pharmaceuticals, Inc., effective October 14, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Ferabright |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Azurity Pharmaceuticals, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA219868 FERABRIGHT | Azurity | October 16, 2025 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | ac666008-a14f-43b4-9d06-ec70f45a4234 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA219868 |
| Active ingredients (FDA) | FERUMOXYTOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — FeraBright, Azurity Pharmaceuticals, Inc., effective October 14, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →