Medications & Supplements/Prescription Drugs

Venofer (Iron Sucrose) Injection Recalled for Glass Delamination Risk

Agency Publication Date: November 29, 2024

Summary

American Regent, Inc. is recalling multiple lots of Venofer (iron sucrose) Injection USP, used to treat iron deficiency anemia, in 50 mg/2.5 mL and 100 mg/5 mL single-dose vials. The recall was initiated because the vials may contain glass delamination, which refers to the shedding of thin glass flakes or particles into the medication liquid. The products were distributed nationwide in the USA to hospitals, wholesalers, and medical facilities through American Regent and Fresenius Medical Care NA.

Risk

Injecting medication that contains glass particles can lead to serious health complications such as inflammation, granulomas in organs, or blood clots that could cause a stroke or heart attack. While no injuries have been reported, the presence of particulate matter in an intravenous drug is a significant safety hazard.

What You Should Do

This recall affects Venofer (iron sucrose) Injection USP single-dose vials in strengths of 50 mg/2.5 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL).
Identify affected products by checking for NDC numbers 49230-534-01, 49230-534-25, 49230-530-01, 49230-530-10, 49230-530-25, 0517-2340-01, 0517-2340-10, or 0517-2340-25. See the Affected Products section below for the full list of affected codes.
Check the lot number and expiration date on the vial label or carton to see if it matches any of the codes listed in this recall.
Stop using the recalled product immediately and isolate any remaining inventory to ensure it is not administered to patients.
Contact American Regent, Inc. or your specific distributor (such as Fresenius Medical Care NA) to arrange for the return of the affected medication.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this safety alert.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL

Variants: 20 mg/mL, 5 mL Single-Dose Vial, Rx Only, For Intravenous Use Only

Lot Numbers:

4196 (Exp 05/31/2026)

NDC:

49230-534-01

49230-534-25

Distributed by Fresenius Medical Care NA, Waltham, MA 02451. Recall #: D-0080-2025

Product: Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL

Variants: 20 mg/mL, 2.5 mL Single-Dose Vial, Rx Only, For Intravenous Use Only

Lot Numbers:

4206 (Exp 05/31/2026)

4210 (Exp 05/31/2026)

4223 (Exp 06/30/2026)

24231 (Exp 07/31/2026)

24237 (Exp 07/31/2026)

NDC:

49230-530-01

49230-530-10

49230-530-25

Distributed by Fresenius Medical Care NA, Waltham, MA 02451. Recall #: D-0081-2025

Product: Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL

Variants: 20 mg/mL, 5 mL Single-Dose Vial, Rx Only, For Intravenous Use Only

Lot Numbers:

4205 (Exp 05/31/2026)

24229 (Exp 07/31/2026)

24233 (Exp 07/31/2026)

24239 (Exp 07/31/2026)

NDC:

0517-2340-01

0517-2340-10

0517-2340-25

American Regent, Inc. Shirley, NY 11967. Recall #: D-0082-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95711

Status: Active

Manufacturer: American Regent, Inc.

Sold By: Fresenius Medical Care NA; Hospitals; Medical Wholesalers; Infusion Centers

Manufactured In: United States

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Venofer (iron sucrose) Injection USP single-dose vials in strengths of 50 mg/2.5 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL).

Identify affected products by checking for NDC numbers 49230-534-01, 49230-534-25, 49230-530-01, 49230-530-10, 49230-530-25, 0517-2340-01, 0517-2340-10, or 0517-2340-25. See the Affected Products section below for the full list of affected codes.

Check the lot number and expiration date on the vial label or carton to see if it matches any of the codes listed in this recall.

Stop using the recalled product immediately and isolate any remaining inventory to ensure it is not administered to patients.

Contact American Regent, Inc. or your specific distributor (such as Fresenius Medical Care NA) to arrange for the return of the affected medication.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this safety alert.

Affected Products

Product: Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL

Variants: 20 mg/mL, 5 mL Single-Dose Vial, Rx Only, For Intravenous Use Only

Lot Numbers:

4196 (Exp 05/31/2026)

NDC:

49230-534-01

49230-534-25

Distributed by Fresenius Medical Care NA, Waltham, MA 02451. Recall #: D-0080-2025

Product: Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL

Variants: 20 mg/mL, 2.5 mL Single-Dose Vial, Rx Only, For Intravenous Use Only

Lot Numbers:

4206 (Exp 05/31/2026)

4210 (Exp 05/31/2026)

4223 (Exp 06/30/2026)

24231 (Exp 07/31/2026)

24237 (Exp 07/31/2026)

NDC:

49230-530-01

49230-530-10

49230-530-25

Distributed by Fresenius Medical Care NA, Waltham, MA 02451. Recall #: D-0081-2025

Product: Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL

Variants: 20 mg/mL, 5 mL Single-Dose Vial, Rx Only, For Intravenous Use Only

Lot Numbers:

4205 (Exp 05/31/2026)

24229 (Exp 07/31/2026)

24233 (Exp 07/31/2026)

24239 (Exp 07/31/2026)

NDC:

0517-2340-01

0517-2340-10

0517-2340-25

American Regent, Inc. Shirley, NY 11967. Recall #: D-0082-2025