Quick answers
- What is Venofer?
- Venofer is a brand name of Iron sucrose, a prescription medicine. The FDA NDC Directory lists 5 Venofer products in 1 strength and form.
- Who makes Venofer?
- Am Regent holds the FDA application for Venofer (NDA021135, approved November 6, 2000). 1 other company (repackagers or distributors) also list Venofer products.
- Is there a generic or store brand of Venofer?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Venofer product. Ask your pharmacist whether one is right for you.
- Has Venofer been recalled?
- FDA enforcement reports list 3 recalls of Venofer products; the newest started November 11, 2024. A recall usually concerns specific lots, not every product.
What Venofer is
Each Venofer product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Iron sucrose · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| iron sucrose 20 mg/mL injection, solution (intravenous) | Venofer | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Iron sucrose →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021135 | Am Regent | November 6, 2000 | 5 |
Companies that list Venofer
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Venofer products.
- American Regent, Inc.3 products
- Fresenius Medical Care Holdings, Inc.2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: 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.
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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.
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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.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.