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Prescription medicine · generic available

Ferumoxytol (ferumoxytol non-stoichiometric magnetite)

Brand names: Feraheme

Drug class: Parenteral Iron Replacement

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
2Companies
2009First FDA approval on file

Quick answers

What is Ferumoxytol (ferumoxytol non-stoichiometric magnetite) used for?
The FDA-approved label (Feraheme, AMAG Pharmaceuticals, Inc, May 31, 2026) says: “Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron or • who have chronic kidney disease (CKD). Feraheme is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ferumoxytol (ferumoxytol non-stoichiometric magnetite) have a boxed warning?
Yes. The FDA label for Feraheme has a boxed warning (“WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Ferumoxytol (ferumoxytol non-stoichiometric magnetite)?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ferumoxytol (ferumoxytol non-stoichiometric magnetite) been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Ferumoxytol (ferumoxytol non-stoichiometric magnetite)?
2 companies list prescription products of Ferumoxytol (ferumoxytol non-stoichiometric magnetite) in the FDA NDC Directory, including Sandoz Inc and AMAG Pharmaceuticals, Inc.

What Ferumoxytol (ferumoxytol non-stoichiometric magnetite) is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron or • who have chronic kidney disease (CKD). Feraheme is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients …

— FDA label: Feraheme, AMAG Pharmaceuticals, Inc, effective May 31, 2026. Read the full label on DailyMed →

The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Chronic kidney disease

Related medical specialties

Nephrology

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: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS. Read it on the full label →

2 of 2 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection
RouteIntravenous
Prescription products2 in the FDA NDC Directory
Brand namesFeraheme

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA022180
FERAHEME		 AzurityJune 30, 2009 17, latest May 27, 2026
2026: Labeling · 2022: Labeling · 2020: Labeling

Generic approvals (1)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)860605, 1191357
SPL set ID of the quoted label32b0e320-a739-11dc-a704-0002a5d5c51b
FDA labels (SPL)2
FDA applicationsNDA022180, 1 ANDA
Active ingredients (FDA)FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Feraheme, AMAG Pharmaceuticals, Inc, effective May 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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