FDAFDA recall D-0653-2026 · Jul 8, 2026
ACCORD BIOPHARMA INC: IMULDOSA recall
Recall found
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 for recall
Lack of assurance of Sterility:
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot # 004L24A, Exp Date: 02/19/2027.
- Quantity
- 326 vials
- Distribution
- US Nationwide.
- Recalling firm
- ACCORD BIOPHARMA INC, Raleigh, NC
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-10
Source: openFDA enforcement record D-0653-2026 · search recall number D-0653-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.