Accord Biopharma Inc: Imuldosa, (ustekinumab-srlf) Injection, 130 Mg/26 Ml (5mg/ml)
Recall Summary Accord BioPharma is recalling IMULDOSA (ustekinumab-srlf) injection 130 mg/26 mL vials distributed nationwide because the company cannot guarantee the product remains sterile. This is a Class II recall affecting a prescription medication used to treat certain immune conditions. The affected vials were manufactured by Catalent Indiana and distributed across all U.S. states and Washington, D.C.
- 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/c382bbf6-4ac2-4ebb-8cb6-de79b0f39f14