FDA Recall D-0081-2025

American Regent, Inc. · Shirley, NY

Class II Ongoing 549 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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).

Lot / code: Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026.

Reason for recall

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

Recall record

Recall number: D-0081-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-11-11
Classified by FDA Center: 2024-11-29
FDA published: 2024-12-11
Recalling firm: American Regent, Inc.
Firm location: Shirley, NY

Drug identification

Brand name(s): VENOFER
Generic name(s): IRON SUCROSE
Manufacturer(s): Fresenius Medical Care Holdings, Inc.
NDC(s): 49230-530, 49230-534
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls