Recalls / Class II
Class IID-0082-2025
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, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).
- Brand name
- Venofer
- Generic name
- Iron Sucrose
- Active ingredient
- Iron Sucrose
- Route
- Intravenous
- NDCs
- 0517-2310, 0517-2325, 0517-2340
- FDA application
- NDA021135
- Affected lot / code info
- Lot #s: 4205, Exp 05/31/2026; 24229, 24233, 24239, 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.
- 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-0082-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.