Recalls / Class II
Class IID-0080-2025
Product
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/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: 4196, Exp 05/31/2026
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-0080-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.