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FDA-Drug2026-05-27Class IIPROCESSING DEFECT

Cimzia (certolizumab pegol) prefilled syringes recalled for lack of sterility assurance

UCB Biosciences
OTHERNationwide distribution

Cimzia prefilled syringes recalled for sterility concerns

UCB Biosciences is recalling specific lots of Cimzia (certolizumab pegol) 200 mg prefilled syringes because the manufacturer cannot confirm the product remained sterile during production. This is a precautionary recall; no infections or injuries have been reported so far.

  • Check if you have Cimzia by finding the lot number on your prefilled syringe box (listed above).
  • If you have an affected lot, contact your pharmacy or doctor before using it.
  • Do not use the product if it is from one of the recalled lots.
Hazard

Lack of Assurance of Sterility

Sold states
US Nationwide.
Affected count
141,708 cartons
Manufactured in
1950 Lake Park Dr SE, Smyrna, GA, United States
Products
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0546-2026

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