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 |
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.
How to identify the recalled item
| Lot / date codes | Lot # 004L24A, Exp Date: 02/19/2027. |
|---|---|
| Lot / date codes | Lot # 004L24A, Exp Date: 02/19/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.