American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, Fo…

Recall date

November 11, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0081-2025

FDA classification

Class II

Brand / firm

American Regent, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Presence of Particulate Matter: Potential for glass delamination from the vials.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).