Accord Biopharma Inc: Imuldosa, (ustekinumab-srlf) Injection, 130 Mg/26 Ml (5mg/ml)
Recall Summary Accord BioPharma is recalling IMULDOSA (ustekinumab-srlf) 130 mg/26 mL injection vials nationwide because the company cannot guarantee the product is sterile. This injectable medication is distributed across all U.S. states and is used to treat certain immune system conditions. The recall affects single-dose vials with NDC number 69448-019-26 manufactured at the Bloomington, Indiana facility.
- Recalling firm
- ACCORD BIOPHARMA INC
- 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.
- Reason
- Lack of assurance of Sterility:
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-10
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/0249f810-6a43-4984-8884-b10763719f53