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, 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).
Lot numbers, UPCs & expiration codes
Lot #s: 4205, Exp 05/31/2026; 24229, 24233, 24239, Exp 07/31/2026.
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-0082-2025
- 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-0082-2025, 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: 4205, Exp 05/31/2026; 24229, 24233, 24239, Exp 07/31/2026.
- Postal code
- 11967-4701
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0082-2025
- 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, 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).
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 11, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 29, 2024