Ustekinumab Recall: Imuldosa Lot 004L24A
Announced 2026-07-08 · FDA
The FDA recall concerns Imuldosa (ustekinumab-srlf) Injection due to lack of assurance of sterility. The recall covers 326 vials distributed nationwide in the United States under Lot 004L24A. The lot's expiration date is 02/19/2027, and no corrective action details are provided.
| Brand | 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: |
| Severity | moderate |
| Units affected | 326 |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Lot # 004L24A, Exp Date: 02/19/2027. |
WHAT YOU SHOULD DO
- Do not use any Imuldosa ustekinumab-srlf injections from Lot 004L24A.
- Contact your healthcare provider or the dispensing pharmacy for guidance and replacement or return instructions.
- Set aside any unused vials from Lot 004L24A and follow disposal instructions from your provider.
- If you experience harm or symptoms, report to FDA MedWatch or your clinician.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.