Class II · ModerateActive recall
Imuldosa
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # 004L24A, Exp Date: 02/19/2027.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of assurance of Sterility:
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAccord 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
| Brand name | IMULDOSA |
| Generic name | USTEKINUMAB-SRLF |
| Active ingredient(s) | USTEKINUMAB-SRLF |
| Distributed by / for | ACCORD BIOPHARMA INC |
| NDC | 69448-019-26 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | ACCORD BIOPHARMA INC |
| Distribution | US Nationwide. |
| Quantity | 326 vials |
| Recall initiated | 2026-06-10 |
| Report date | 2026-07-08 |
| Recall completed | — |
| Recall number | D-0653-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Raleigh NC United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.