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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
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 23, 2026 at 11:04 PM UTC.
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