Skip to content
Back to recalls
Drug FDA Class II Ongoing Foreign material

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).

American Regent, Inc. Published Dec 11, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact American Regent, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of Particulate Matter: Potential for glass delamination from the vials.

Hazards

Glass Particulate · primary

Affected products (1)

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).

VENOFER

NDC: 0517-2310, 0517-2325, 0517-2340, 0517-2325-01, 0517-2325-10, 0517-2340-01, 0517-2340-10, 0517-2340-25, 0517-2310-01, 0517-2310-05
Code info: Lot #s: 4205, Exp 05/31/2026; 24229, 24233, 24239, Exp 07/31/2026.

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 11, 2024
  2. Published
    Dec 11, 2024
Recall number
D-0082-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.