CIMZIA injection recalled due to lack of sterility assurance
UCB Biosciences is recalling CIMZIA (certolizumab pegol) prefilled syringes nationwide because of a lack of assurance of sterility. Affected lots are distributed across the US.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Loss of sterility assurance in a systemic injectable drug poses a significant infection risk and meets the criteria for Severe classification when paired with the FDA Class II designation.
Plain-English summary
UCB Biosciences Inc. is recalling CIMZIA (certolizumab pegol) 200mg/mL prefilled syringes nationwide. The recall affects 141,708 cartons due to a lack of assurance of sterility.
The recall includes multiple lot codes with expiration dates ranging from July 2026 to December 2026. Affected lots include CVZFW, CVZYG, CWSYT, CWDZY, CWTSD, CVTFK, CVTSN, CWVGP, CVWXT, CVWXV, CVWXW, CWHFF, and CWNDS.
This is a prescription medication used to treat certain inflammatory conditions. Patients using affected lots should consult their healthcare provider about the recall and whether their medication may be impacted. Additional information is available from the FDA's drug safety and availability website.
The recalled product
- Product
- CIMZIA (CERTOLIZUMAB PEGOL)
- Brand
- CIMZIA
- Manufacturer
- UCB Biosciences Inc.
- Category
- Drug — Injectable / Biologic
- Affected units
- 141,708
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- 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
- CVTSN
- CWVGP. Exp.:2026-DEC-11
- CVWXT
- CVWXV
- CVWXW
- CWHFF
- CWNDS
- Exp.: 2026-DEC-11.
Distribution
Distributed nationwide across the United States.
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