American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For
American Regent recalls Venofer iron injection vials due to potential glass delamination. Stop using if you have these vials.
Use caution until it’s fixed
Presence of Particulate Matter: Potential for glass delamination from the vials.
Contact the company & request your remedy
What happened, in plain English
American Regent is recalling Venofer iron injection vials because glass may separate inside the vial. This could cause injury if the glass particles enter the bloodstream during IV use. Read more at govinfonow.com/recall/32445-american-regent-venofer-injection-recall-glass-delamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32445-american-regent-venofer-injection-recall-glass-delamination-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0080-2025
Cite this page
“American Regent Venofer injection recall: Glass delamination risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32445-american-regent-venofer-injection-recall-glass-delamination-risk. Based on FDA recall #D-0080-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0080-2025%22&limit=1).
Why it’s dangerous
Glass particles can break off from the vial and enter the bloodstream during IV infusion. This could cause serious injury or infection if particles reach the bloodstream.
Who’s affected
Patients receiving Venofer injections via IV. Those with vials from specific lots or cartons are most at risk.
How to tell if you have this one
Check for vials with NDC 49230-534-01 (single dose) or 49230-534-25 (25 vials per carton). Lot numbers 4196 with expiration 05/31/2026.
- Brand
American Regent- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0080-2025 | 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#s: 4196, Exp 05/31/2026 | — | 49230-530-01, 49230-530-10, 49230-530-25, 49230-534-01, 49230-534-10, 49230-534-25 |
| D-0081-2025 | Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).; Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026. | — | 49230-530-01, 49230-530-10, 49230-530-25, 49230-534-01, 49230-534-10, 49230-534-25 |
| D-0082-2025 | 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 #s: 4205, Exp 05/31/2026; 24229, 24233, 24239, Exp 07/31/2026. | — | 0517-2325-01, 0517-2325-10, 0517-2340-01, 0517-2340-10, 0517-2340-25, 0517-2310-01, 0517-2310-05 |
What to do — step by step
Check Vial Details
Identify your vial by NDC number or lot number to confirm if it's recalled.
Stop Using if Recalled
If you have recalled vials, stop using them immediately and contact your healthcare provider.
Questions people ask
Why is this vial being recalled?
The recall is for potential glass delamination, which could cause glass particles to enter the bloodstream during IV use.
How can I tell if I have a recalled vial?
Check for NDC 49230-534-01 (single dose) or 49230-534-25 (25 vials per carton) with lot number 4196 expiring 05/31/2026.
What should I do if I have a recalled vial?
Stop using the vial immediately and contact your healthcare provider for instructions.
Contact American Regent
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0080-2025 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0080-2025 from American Regent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0080-2025 (November 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0080-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.