Quick answers
- What is Iron sucrose used for?
- The FDA-approved label (Venofer, American Regent, Inc., March 1, 2026) says: “Venofer 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).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Iron sucrose have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Iron sucrose?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated May 21, 2026). Ask your pharmacist about alternatives.
- Has Iron sucrose been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started November 11, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Iron sucrose?
- 6 companies list prescription products of Iron sucrose in the FDA NDC Directory, including American Regent, Inc., Sandoz Inc and International Medication Systems, Limited.
What Iron sucrose is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Venofer 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).
— FDA label: Venofer, American Regent, Inc., effective March 1, 2026. Read the full label on DailyMed →
The FDA has 7 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.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous · Intravitreal |
| Prescription products | 15 in the FDA NDC Directory |
| Brand names | Venofer |
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.
- American Regent, Inc.4 products
- Sandoz Inc3 products
- International Medication Systems, Limited3 products
- Mylan Institutional LLC3 products
- Fresenius Medical Care Holdings, Inc.2 products
- HF Acquisition Co LLC, DBA HealthFirst1 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 |
|---|---|---|---|
| NDA021135 VENOFER | Am Regent | November 6, 2000 | 24, latest March 2, 2026 2026: Manufacturing (CMC) · 2024: Labeling · 2021: Labeling |
Generic approvals (3)
- ANDA208977Intl Medication Sys · August 8, 2025
- ANDA212340Sandoz · August 8, 2025
- ANDA212559Mylan Labs Ltd · August 8, 2025
Shortage status
To be discontinued · updated May 21, 2026 · first posted May 21, 2026
| Product | Iron Sucrose, Injection, 50 mg/2.5 mL (NDC 67457-957-99) |
|---|---|
| Company | Mylan Institutional, a Viatris Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 11, 2024 · Class II · Ongoing · D-0081-2025
Presence of Particulate Matter: Potential for glass delamination from the vials.
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530- — American Regent, Inc.
-
November 11, 2024 · Class II · Ongoing · D-0080-2025
Presence of Particulate Matter: Potential for glass delamination from the vials.
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 — American Regent, Inc.
-
November 11, 2024 · Class II · Ongoing · D-0082-2025
Presence of Particulate Matter: Potential for glass delamination from the vials.
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-234 — American Regent, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Venofer, American Regent, Inc., effective March 1, 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 →