Class IIOngoing
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
By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Jul 8, 2026How we research
ACCORD BIOPHARMA INC recalled IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single d… 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:
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 d… recalled?
- ACCORD BIOPHARMA INC recalled IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single d… 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 d… 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 d… 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 d… are affected?
- Distribution: US Nationwide.. The affected lot numbers and expiration dates are listed in the official FDA enforcement record for recall D-0653-2026, initiated Jun 2026.