FDA recall, , Moderate risk
Accord BioPharma Imuldosa Injection
Imuldosa injection lacks assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Accord BioPharma Inc. of Raleigh, North Carolina recalled 326 vials of Imuldosa, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, because of lack of assurance of sterility. The product was distributed nationwide. The recall began June 10, 2026, and was added to the FDA's Enforcement Report on June 29, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
IMULDOSA, (ustekinumab-srlf) Injection
- NDC
- 69448-019-26
- Lot code
- 004L24A
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- ACCORD BIOPHARMA INCRaleigh, North Carolina
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99216
- Recall number
- D-0653-2026
- Quantity recalled
- 326 vials
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
