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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#s: 4196, Exp 05/31/2026
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- American Regent, Inc.
- Reason for Recall:
- Presence of Particulate Matter: Potential for glass delamination from the vials.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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).
Product Codes/Lot Numbers:
Lot#s: 4196, Exp 05/31/2026
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0080-2025
Related Recalls
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Presence of Particulate Matter: Potential for glass delamination from the vials.