Accord IMULDOSA Injection Recall: Sterility Risk in Single-Dose Vials
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.
Recall notice
Lack of assurance of Sterility:
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/31210-accord-imuldosa-injection-recall-sterility-risk-in-single-dose-vials.
Source Summary by GovInfoNow · govinfonow.com/recall/31210-accord-imuldosa-injection-recall-sterility-risk-in-single-dose-vials · Updated August 10, 2026 · FDA enforcement record: FDA #D-0653-2026
Cite this page
“Accord IMULDOSA Injection Recall: Sterility Risk in Single-Dose Vials.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31210-accord-imuldosa-injection-recall-sterility-risk-in-single-dose-vials. Based on FDA recall #D-0653-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0653-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Prescription patients using IMULDOSA injections. Those with the specific lot number 004L24A are at higher risk.
How to tell if you have this one
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.
- Brand
Accord- Category
Drug
What to do — step by step
Check Product Label
Look for the product name and lot number on the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states there is a lack of assurance of sterility, so it is not safe to use without checking the recall status.
How can I find out if I have the recalled product?
Check the product label for lot number 004L24A or contact Accord BioPharma at 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA.
Similar recalls
Latest drug recalls
Keep exploring
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-0653-2026 (June 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0653-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.