FDA-Drug2026-07-08Class IIPROCESSING DEFECT
Accord BioPharma IMULDOSA injection recalled for lack of sterility assurance
What this means
Accord BioPharma is recalling one lot of IMULDOSA (ustekinumab-srlf) injection due to lack of assurance that the product is sterile. The affected lot may not meet sterility standards required for injectable medications. No injuries have been reported.
- If you have IMULDOSA lot #004L24A (expiration 02/19/2027), contact your healthcare provider or pharmacy immediately.
- Do not use the product if you have it.
- Your healthcare provider can discuss next steps for your treatment.
The agency's original wording
Hazard
Lack of assurance of Sterility:
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
326 vials
Manufactured in
8041 Arco Corporate Dr Ste 200, N/A, Raleigh, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0653-2026Want us to check the next one for you?
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