Accord BioPharma recalls IMULDOSA (ustekinumab-srlf) injections due to potential sterility issues. This medication is prescription-only and may be affected by specific lot numbers. Contact the manufacturer for details.
Lack of assurance of Sterility:
Accord BioPharma is recalling IMULDOSA injections because they may not be sterile. This could lead to infections if the medication is used. Patients with this prescription should contact their doctor or the manufacturer.
The injection vials may not be sterile, which could cause infections if the medication is administered. This is a serious risk for patients receiving the drug.
Prescription patients using IMULDOSA injections. Those with the specific lot number 004L24A are at higher risk.
Check the product label for 'IMULDOSA (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial'. Look for lot number 004L24A.
Look for the product name and lot number on the vial.
The recall states there is a lack of assurance of sterility, so it is not safe to use without checking the recall status.
The recall does not specify a remedy, so contact your doctor or the manufacturer for guidance.
Check the product label for lot number 004L24A or contact Accord BioPharma at 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA.
We’ve drafted a message you can send Accord to request your refund or repair — edit it as you like.
Subject: Recall D-0653-2026 — Accord Accord Hello, I own a Accord that is covered by recall D-0653-2026 from Accord. 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.
