Prescription medicine
Ferric carboxymaltose Brand names: Injectafer
Ferric carboxymaltose (Injectafer) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the ferric carboxymaltose FDA label on DailyMed (effective August 19, 2026, American Regent, Inc.); the NDA 203565 record on Drugs@FDA; every ferric carboxymaltose label on DailyMed.
Highlights of the record
FDA label of August 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SYMPTOMATIC HYPOPHOSPHATEMIA •.
INJECTAFER can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention [see Warnings and Precautions (5.1)].
Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia [see Warnings and Precautions (5.1)].
Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months [see Dosage and Administration (2.1 , 2.3) ]. Correct pre-existing hypophosphatemia prior to administering INJECTAFER [see Warnings and Precautions (5.1)].
Advise patients receiving INJECTAFER about the risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures) [see Warnings and Precautions (5.1)]. WARNING: SYMPTOMATIC HYPOPHOSPHATEMIA See full prescribing information for complete boxed warning. INJECTAFER can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention ( 5.1 ). […]
Used for
From the label: indications and usageInjectafer 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.
Forms and strengths
- 50 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- July 25, 2013 Injectafer, Am Regent; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first June 25, 2026; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 15, 2028 Injectafer injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 4,632 through July 30, 2026
What is ferric carboxymaltose used for?
From the label: indications and usageInjectafer 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. Injectafer is an iron replacement product 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. […]
FDA pharmacologic class: Parenteral Iron Replacement and Phosphate Binder.
Source: FDA drug label (Injectafer), American Regent, Inc., effective August 19, 2026 (SPL set 517b4a19-45b3-4286-9f6a-ced4e10447de), via openFDA; the full label on DailyMed
What does the patient leaflet for ferric carboxymaltose say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about INJECTAFER?INJECTAFER can cause serious side effects, including: Low blood phosphate levels (hypophosphatemia). Hypophosphatemia has happened after one or more doses of INJECTAFER and can be severe or serious, and lead to hospitalization, softening of your bones (osteomalacia), and broken bones (fractures). Hypophosphatemia can happen even if your blood phosphate levels were normal before treatment and you do not have any risk factors for hypophosphatemia. Your healthcare provider will check your blood phosphate levels before a repeat treatment with INJECTAFER if you are at risk for hypophosphatemia. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider will check your blood phosphate levels. Tell your healthcare provider if you develop any of the following signs or symptoms of hypophosphatemia during treatment with INJECTAFER: • tiredness • bone or joint pain • muscle weakness or pain • broken bones Your healthcare provider may permanently stop treatment with INJECTAFER if you develop sever hypophosphatemia with symptoms or if your blood phosphate levels remain low during treatment with INJECTAFER. See “What are the possible side effects of INJECTAFER?” For more information about side effects.
Source: FDA drug label (Injectafer), American Regent, Inc., effective August 19, 2026 (SPL set 517b4a19-45b3-4286-9f6a-ced4e10447de), via openFDA; the full label on DailyMed
Is there a generic for ferric carboxymaltose (Injectafer)?
The FDA approved the first generic ferric carboxymaltose on June 25, 2026. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ferric carboxymaltose from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Injectafer injection: the compound patent runs to February 5, 2027, and the last listed entry to February 15, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2026 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has ferric carboxymaltose been recalled?
The FDA's Enforcement Report lists 1 recall naming ferric carboxymaltose since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for ferric carboxymaltose?
The FDA Adverse Event Reporting System holds 4,632 reports that list ferric carboxymaltose among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 90 are coded as a death and 607 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other parenteral iron replacements
- the pharmacologic class, with prices and generics
- Ferric carboxymaltose side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other