Why it was recalled
Presence of Particulate Matter: Potential for glass delamination from the vials.
Product 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).
Lot numbers, UPCs & expiration codes
Lot#s: 4196, Exp 05/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0080-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 11, 2024
- FDA report date
- Dec 11, 2024
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Regent, Inc.
Original FDA data
Every field from FDA enforcement report D-0080-2025, exactly as published.
Show all FDA fields
- City
- Shirley
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 95711
- Address
- 5 Ramsey Rd
- Code information
- Lot#s: 4196, Exp 05/31/2026
- Postal code
- 11967-4701
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0080-2025
- Classification
- Class II
- Recalling firm
- American Regent, Inc.
- Reason for recall
- Presence of Particulate Matter: Potential for glass delamination from the vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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).
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 11, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 29, 2024