FDA recall, , Moderate risk
UCB Cimzia Prefilled Syringes
Cimzia (certolizumab pegol) prefilled syringes lack assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
UCB Biosciences Inc. of Smyrna, Georgia is recalling cimzia (certolizumab pegol) prefilled syringes because of a lack of assurance of sterility. The affected products are 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, manufactured by UCB Inc., including a professional sample and a STARTER KIT with 3 cartons. The recall began May 8, 2026, was added to the FDA's Enforcement Report on May 20, 2026, and distributed nationwide in the US. The company recalled 141,708 cartons.
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.
cimzia (certolizumab pegol), 2x200mg/mL Prefilled Syringes
- NDC
- 50474-710-79
- 50474-710-80
- 50474-710-81
- Lot code
- 2026-JUL-04
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- UCB Biosciences Inc.Smyrna, Georgia
- 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
- 98915
- Recall number
- D-0546-2026
- Quantity recalled
- 141,708 cartons
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
