FDAFDA · Food and drugs·Recall number D-0082-2025

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: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).

Name: 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: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).
Brand: VENOFER

Published December 11, 2024 · Recall initiated: November 11, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand: VENOFER
Manufacturer: American Regent, Inc.
Distributor: Nationwide in the USA
UPC: 0305172340016
Lot: Lot #s: 4205, Exp 05/31/2026; 24229, 24233, 24239, Exp 07/31/2026.
Risk classification: Class II
Area (FDA): drug
Country: United States

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