Class IIOngoing

Venofer (iron sucrose) Injection recall

FDA recall D-0081-2025 · initiated Nov 11, 2024

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.

Details

Product: 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: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/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 →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0081-2025 ↗

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