American Regent recalls Venofer iron injection vials due to potential glass particles causing injury. Stop using if you have these specific vial lots.
Presence of Particulate Matter: Potential for glass delamination from the vials.
American Regent is recalling Venofer iron injection vials because glass particles could be released, potentially causing injury. This affects patients receiving intravenous iron treatments.
Glass particles can detach from the vial during use, which may enter the bloodstream and cause injury. This risk is higher if the vial is damaged or improperly handled.
Patients receiving intravenous iron treatments via Venofer vials are most at risk. Healthcare providers using these vials for medical administration may also be affected.
Check for vials labeled 'Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials'. Look for lot numbers 4205 (expiring 05/31/2026) or 24229, 24233, 24239 (expiring 07/31/2026).
Look for lot numbers 4205 (expiring 05/31/2026) or 24229, 24233, 24239 (expiring 07/31/2026) on the vial packaging.
If you have the recalled vials, stop using them immediately to prevent potential injury from glass particles.
The vials may release glass particles during use, which could enter the bloodstream and cause injury.
Check for vials labeled 'Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials' with lot numbers 4205 (expiring 05/31/2026) or 24229, 24233, 24239 (expiring 07/31/2026).
Stop using the vials immediately to prevent potential injury from glass particles.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0082-2025 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0082-2025 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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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.
