ACCORD BIOPHARMA INC recalls IMULDOSA
- Recalling company
- ACCORD BIOPHARMA INC
- 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
- Lack of assurance of Sterility:
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 10, 2026
- Reported
- Jul 8, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- 326 vials
- Lot / codes
- Lot # 004L24A, Exp Date: 02/19/2027.
- Company location
- Raleigh, NC
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0653-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0653-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.