cimzia (certolizumab pegol) recall
FDA recall D-0546-2026 · initiated May 8, 2026
UCB Biosciences Inc. recalled cimzia (certolizumab pegol) in May 2026 — an FDA Class II recall (D-0546-2026) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 141,708 cartons
Details
- 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.
- Recalling company
- UCB Biosciences Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- May 8, 2026
- FDA report date
- May 27, 2026
This recall is linked to a product we cover: Cimzia →
Frequently asked
- Was cimzia (certolizumab pegol) recalled?
- UCB Biosciences Inc. recalled cimzia (certolizumab pegol) in May 2026 — an FDA Class II recall (D-0546-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was cimzia (certolizumab pegol) recalled?
- Per the FDA enforcement record, the reason for recall D-0546-2026 was: Lack of Assurance of Sterility
- Is a recalled cimzia (certolizumab pegol) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of cimzia (certolizumab pegol) are affected?
- Distributed: US Nationwide.. The recall covers these 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.…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0546-2026.