CLASS II ONGOING Drug recall · Reported 11 Dec 2024 · FDA Enforcement Report
Venofer (iron sucrose) Injection recalled by American Regent
American Regent is recalling Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per (20 mg/mL) Single-Dose, distributed nationwide in the US. The recall was initiated on 11 Nov 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0081-2025
- FDA event ID
- 95711
- Recalling firm
- American Regent, Shirley, NY
- Brand
- Venofer
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Nov 2024
- FDA classified
- 29 Nov 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Nov 2024 | Recall initiated by company | |
| 29 Nov 2024 | Classified by FDA | +18 days |
| 11 Dec 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Potential for glass delamination from the vials.
Product as listed by the FDA
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).
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Potential for glass delamination from the vials.
Which lots are affected?
Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95711This product is part of a recall event; the main page for the event is Venofer (iron sucrose) Injection recalled by American Regent.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Venofer (iron sucrose) Injection recalled by American RegentVenofer | American Regent | Particulate Matter | Nationwide | |
| CLASS II | Venofer (iron sucrose) Injection recalled by American RegentVenofer | American Regent | Particulate Matter | Nationwide |
More recalls from American Regent
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Tralement (trace elements injection 4*, USP) recalled by American RegentTralement | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalledSelenious Acid | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid | American Regent | Particulate Matter | Nationwide |
Other Iron Sucrose recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Venofer (iron sucrose) Injection recalled by American RegentVenofer | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Venofer (iron sucrose) Injection recalled by American RegentVenofer | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Iron Sucrose 200 mg / NS Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |