CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report
Imuldosa, (ustekinumab-srlf) Injection, 130 mg/ (5mg/mL) recalled
Accord Biopharma is recalling Imuldosa, (ustekinumab-srlf) Injection, 130 mg/ (5mg/mL), distributed nationwide in the US. The recall was initiated on 10 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0653-2026
- FDA event ID
- 99216
- Recalling firm
- Accord Biopharma, Raleigh, NC
- Brand
- Imuldosa
- Manufacturer
- Accord BioPharma Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jun 2026
- FDA classified
- 29 Jun 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Jun 2026 | Recall initiated by company | |
| 29 Jun 2026 | Classified by FDA | +19 days |
| 8 Jul 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of Sterility:
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Lack of assurance of Sterility:
Which lots are affected?
Lot # 004L24A, Exp Date: 02/19/2027.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.