FDA recall D-0546-2026

Product

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 for recall

Lack of Assurance of Sterility

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-05-08

Report date

2026-05-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Smyrna, GA, United States

Primary source

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