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.
Recall at a glance
- Quantity recalled
- 326 vials
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
- Lot code
- 004L24A, 2027
- Strength
- 130 mg
- NDC / UPC
- NDC 69448-019-26
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Editorial summary by Recall Canary · summary updated 2026-06-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification