Imuldosa (ustekinumab-srlf) Injection
Accord BioPharma is recalling Imuldosa (ustekinumab-srlf) 130 mg/26 mL injection vials due to a lack of assurance of sterility.
Stop using this product immediately and contact your healthcare provider for an alternative treatment. Return the affected product to the place of purchase or contact Accord BioPharma for further instructions.
Why it was recalled
Accord BioPharma is recalling this injectable medication due to a lack of assurance of sterility. The recall affects single-dose vials of the 130 mg/26 mL strength.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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 at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.
- Recall #
- D-0653-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification