Class II Recall

American Regent, Inc.

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).
Reason
Presence of Particulate Matter: Potential for glass delamination from the vials.
Classification
Class II
Status
Ongoing
Lot
Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.