Venofer (iron sucrose) Injection recall
FDA recall D-0080-2025 · initiated Nov 11, 2024
American Regent, Inc. recalled Venofer (iron sucrose) Injection in Nov 2024 — an FDA Class II recall (D-0080-2025) because Presence of Particulate Matter: Potential for glass delamination from the vials.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: Potential for glass delamination from the vials.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- 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 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
- Recalling company
- American Regent, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Nov 11, 2024
- FDA report date
- Dec 11, 2024
This recall is linked to a product we cover: Venofer →
Frequently asked
- Was Venofer (iron sucrose) Injection recalled?
- American Regent, Inc. recalled Venofer (iron sucrose) Injection in Nov 2024 — an FDA Class II recall (D-0080-2025) because Presence of Particulate Matter: Potential for glass delamination from the vials. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Venofer (iron sucrose) Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0080-2025 was: Presence of Particulate Matter: Potential for glass delamination from the vials.
- Is a recalled Venofer (iron sucrose) Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Venofer (iron sucrose) Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot#s: 4196, Exp 05/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0080-2025.