Cimzia recalled over sterility concerns
- Recall date
- May 8, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- UCB Biosciences Inc. recalls cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna,…
- Recall number
- D-0546-2026
- FDA classification
- Class II
- Brand / firm
- UCB Biosciences Inc.
- Sold / distributed
- US Nationwide.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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