Prescription medicine
Iron sucrose Brand names: Venofer
Iron sucrose (Venofer) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the iron sucrose FDA label on DailyMed (effective March 1, 2026, American Regent, Inc.); the NDA 21135 record on Drugs@FDA; every iron sucrose label on DailyMed.
Highlights of the record
FDA label of March 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVenofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
Forms and strengths
- 20 mg/ml
- 50 mg/2.5ml
- 100 mg/5ml
- 200 mg/10ml
Injection (solution); injection.
On the market
- Earliest approval on file
- November 6, 2000 Venofer, Am Regent; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first August 8, 2025; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 3 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 4 since 2019 0 Class I among all firms' recalls; latest November 11, 2024
- FAERS reports
- 9,479 through July 30, 2026
What is iron sucrose used for?
From the label: indications and usageVenofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Venofer is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
Conditions named in the indications of iron sucrose's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Parenteral Iron Replacement and Phosphate Binder.
Source: FDA drug label (Venofer), American Regent, Inc., effective March 1, 2026 (SPL set 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a), via openFDA; the full label on DailyMed
Is there a generic for iron sucrose (Venofer)?
The FDA approved the first generic iron sucrose on August 8, 2025. 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 iron sucrose from 3 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2000 earliest approval on file
- 2025 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is iron sucrose in shortage?
No iron sucrose presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated May 21, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Iron Sucrose, Injection, 50 mg/2.5 mL (NDC 67457-957-99) | Mylan Institutional, a Viatris Company | To Be Discontinued | May 21, 2026 |
Every iron sucrose presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has iron sucrose been recalled?
The FDA's Enforcement Report lists 4 recalls naming iron sucrose since 2019: 0 Class I (the most serious), 4 Class II, 0 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 11, 2024 | Class II | American Regent, Inc. | Presence of Particulate Matter: Potential for glass delamination from the vials. |
| 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 iron sucrose?
The FDA Adverse Event Reporting System holds 9,479 reports that list iron sucrose among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 921 are coded as a death and 3,240 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 else is labeled for the same conditions as iron sucrose?
8 other medicines are given the same way (intravenous) and in the same FDA class as iron sucrose or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ferumoxytol | Anemia | 1 labeler | n/a | No current entry |
| Sodium ferric gluconate complex | Anemia | 1 labeler | n/a | No current entry |
| Epoetin | Anemia | none listed | $32.27 per mL 2,000 units/mL vial | No current entry |
| Darbepoetin alfa | Anemia | none listed | $446.58 per mL 25 mcg/0.42 mL syring | No current entry |
| Methoxy polyethylene glycol-epoetin beta | Anemia | none listed | n/a | No current entry |
| Ferric derisomaltose | Anemia | none listed | n/a | No current entry |
| Imetelstat | Anemia | none listed | n/a | No current entry |
| Nipocalimab | Anemia | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as iron sucrose
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to iron sucrose
- 8 medicines for the same use
- Other parenteral iron replacements
- the pharmacologic class, with prices and generics
- Iron sucrose side effects
- the label's list beside FAERS reports
- Iron sucrose shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other