ACCORD BIOPHARMA INC recalls IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPhar
Recalled July 8, 2026 · FDA recall D-0653-2026 · ACCORD BIOPHARMA
Hazard
Lack of assurance of Sterility: · FDA Class II
Units
326 vials
Sold at
US Nationwide.
Description
Lack of assurance of Sterility:
Product
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.
Manufacturer(s)
ACCORD BIOPHARMA INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →