IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial… recall
FDA recall D-0653-2026 · initiated Jun 10, 2026
ACCORD BIOPHARMA INC recalled IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single… in Jun 2026 — an FDA Class II recall (D-0653-2026) because Lack of assurance of Sterility:.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of assurance of Sterility:
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 326 vials
Details
- 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.
- Recalling company
- Accord Biopharma Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jun 10, 2026
- FDA report date
- Jul 8, 2026
This recall is linked to a product we cover: Imuldosa →
Frequently asked
- Was IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single… recalled?
- ACCORD BIOPHARMA INC recalled IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single… in Jun 2026 — an FDA Class II recall (D-0653-2026) because Lack of assurance of Sterility:. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single… recalled?
- Per the FDA enforcement record, the reason for recall D-0653-2026 was: Lack of assurance of Sterility:
- Is a recalled IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single… are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # 004L24A, Exp Date: 02/19/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0653-2026.