FDAClass II · Drug · Recalled May 27, 2026

cimzia (certolizumab pegol) recall — UCB Biosciences Inc.

Hazard: Lack of Assurance of Sterility

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0546-2026
Brand: UCB Biosciences
Classification: Class II
Units affected: 141,708 cartons
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

cimzia (certolizumab pegol)

Companies & origin

Recalling firm location: Smyrna, GA, United States
Firm address: 1950 Lake Park Dr SE, 30080-7648

Identifying details (verbatim from the notice)

Product codes / lots: Lot: CVZFW, Exp.:2026-JUL-04; CVZYG, Exp.: 2026-AUG-19; CWSYT, Exp.: 2026-OCT-22; CWDZY, Exp.:2026-NOV-20; CWTSD, Exp.:2026-DEC-11; CVTFK, Exp.:2026-JUL-04; CVTSN, Exp.: 2026-AUG-19; CWVGP. Exp.:2026-DEC-11; CVWXT, CVWXV, CVWXW, Exp.:2026-JUL-04; CWHFF, Exp.: 2026-OCT-22; CWNDS, Exp.: 2026-DEC-11.
Distribution: US Nationwide.
Firm notified the public via: Letter
FDA event ID: 98915
Recall initiated: May 8, 2026
FDA classified: May 20, 2026
FDA report date: May 27, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

Report a data error on this page