Quick Facts at a Glance
- Recall Date
- June 10, 2026
- Hazard Level
- HIGH
- Brands
- IMULDOSA, Accord BioPharma Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- IMULDOSA, Accord BioPharma Inc.
- Model numbers
- Lot # 004L24A, Exp Date: 02/19/2027.
- UPC codes
- 69448-017, 69448-018, 69448-019, 69448-018-63, 69448-017-63, 69448-019-26
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 10, 2026
Reported by FDA DRUG
July 8, 2026
RecallRadar source check
July 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of assurance of Sterility:
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact ACCORD BIOPHARMA INC or your healthcare provider for guidance. Notification method: Letter
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Full Description
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.. Generic: USTEKINUMAB-SRLF; Brand: IMULDOSA. Reason: Lack of assurance of Sterility:. Classification: Class II. Quantity: 326 vials. Distribution: US Nationwide.
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Safety Guide
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