← FDA ENFORCEMENT
D-0081-2025Class II

American Regent, Inc.

Recalling firm
American Regent, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
Nationwide in the USA
Firm state
NY
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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).

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.