Recall Ledger

cimzia recall (UCB Biosciences Inc.)

DrugClass IIOngoing

Summary: UCB Biosciences Inc. is recalling 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.. Reason: Lack of Assurance of Sterility.

What is being 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.

Why

Lack of Assurance of Sterility

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide.

How to tell if yours is affected

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.

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0546-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMay 8, 2026
ReportedMay 27, 2026
CompanyUCB Biosciences Inc.
Company locationSmyrna, GA, United States
Initiated byVoluntary: Firm initiated
Quantity141,708 cartons

More recalls from UCB Biosciences Inc. · all drug recalls · recalls from May 2026

Official FDA record