Recalls / Class II
Class IID-0081-2025
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).
- Brand name
- Venofer
- Generic name
- Iron Sucrose
- Active ingredient
- Iron Sucrose
- Route
- Intravenous
- NDCs
- 49230-530, 49230-534
- FDA application
- NDA021135
- Affected lot / code info
- Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026.
Why it was recalled
Presence of Particulate Matter: Potential for glass delamination from the vials.
Recalling firm
- Firm
- American Regent, Inc.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5 Ramsey Rd, Shirley, New York 11967-4701
Distribution
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-11-11
- FDA classified
- 2024-11-29
- Posted by FDA
- 2024-12-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0081-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.