American Regent recalls Venofer iron injection vials due to potential glass delamination. Stop using if you have these vials.
Presence of Particulate Matter: Potential for glass delamination from the vials.
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.
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.
Patients receiving Venofer injections via IV. Those with vials from specific lots or cartons are most at risk.
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.
Identify your vial by NDC number or lot number to confirm if it's recalled.
If you have recalled vials, stop using them immediately and contact your healthcare provider.
The recall is for potential glass delamination, which could cause glass particles to enter the bloodstream during IV use.
Check for NDC 49230-534-01 (single dose) or 49230-534-25 (25 vials per carton) with lot number 4196 expiring 05/31/2026.
Stop using the vial immediately and contact your healthcare provider for instructions.
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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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.
