Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Venofer (iron sucrose) Injection Recalled by American Regent, Inc. Due to Presence of Particulate Matter: Potential for glass delamination...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Regent, Inc. directly.
Affected Products
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).
Why Was This Recalled?
Presence of Particulate Matter: Potential for glass delamination from the vials.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Regent, Inc.
American Regent, Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report