Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord…
Accord Biopharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ACCORD BIOPHARMA INC · 8041 Arco Corporate Dr Ste 200 · Raleigh, NC · 27617-2091
Is this the product you have?
- IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA
- Manufactured atCatalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26
- Lot codes and dates
- Lot # 004L24A
- Exp Date02/19/2027
- Amount recalled
- 326 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of assurance of Sterility:
This product could cause temporary or reversible health problems — stop using it.
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