Quick answers
- What is Ferric carboxymaltose used for?
- The FDA-approved label (Injectafer, American Regent, Inc., August 19, 2026) says: “Injectafer is indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease. • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ferric carboxymaltose have a boxed warning?
- Yes. The FDA label for Injectafer has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ferric carboxymaltose?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ferric carboxymaltose been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ferric carboxymaltose?
- 3 companies list prescription products of Ferric carboxymaltose in the FDA NDC Directory, including Mylan Institutional LLC, American Regent, Inc. and Sandoz Inc.
What Ferric carboxymaltose is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Injectafer is indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease. • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. …
— FDA label: Injectafer, American Regent, Inc., effective August 19, 2026. Read the full label on DailyMed →
The FDA has 3 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.
Related medical specialties
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. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Injectafer |
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.
- Mylan Institutional LLC3 products
- American Regent, Inc.3 products
- Sandoz Inc1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA203565 INJECTAFER | Am Regent | July 25, 2013 | 16, latest August 13, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
Generic approvals (3)
- ANDA212572Mylan Labs Ltd · June 25, 2026
- ANDA217076Mylan · June 25, 2026
- ANDA217769Mylan · June 25, 2026
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Injectafer, American Regent, Inc., effective August 19, 2026; 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 →