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, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (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, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).

VENOFER

NDC: 49230-530, 49230-534, 49230-530-01, 49230-530-10, 49230-530-25, 49230-534-01, 49230-534-10, 49230-534-25

Code info: Lot#s: 4196, Exp 05/31/2026

Affected areas

Nationwide

Timeline

Initiated

Nov 11, 2024
Published

Dec 11, 2024

Recall number: D-0080-2025
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.