Why it was recalled
Lack of assurance of Sterility:
Product 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.
Lot numbers, UPCs & expiration codes
Lot # 004L24A, Exp Date: 02/19/2027.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0653-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 10, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- 326 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ACCORD BIOPHARMA INC
Original FDA data
Every field from FDA enforcement report D-0653-2026, exactly as published.
Show all FDA fields
- City
- Raleigh
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 99216
- Address
- 8041 Arco Corporate Dr Ste 200
- Code information
- Lot # 004L24A, Exp Date: 02/19/2027.
- Postal code
- 27617-2091
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0653-2026
- Classification
- Class II
- Recalling firm
- ACCORD BIOPHARMA INC
- Product quantity
- 326 vials
- Reason for recall
- Lack of assurance of Sterility:
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Jun 10, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2026