Certolizumab pegol Recall: Cimzia
FDA is recalling Cimzia (certolizumab pegol) 2x200 mg/mL prefilled syringes (Rx only) manufactured by UCB Inc. due to lack of assurance of sterility. The recall affects about 141,708 cartons distributed nationwide in the US and covers multiple lots with various expiration dates. Lot numbers include CVZFW, CVZYG, CWSYT, CWDZY, CWTSD, CVTFK, CVTSN, CWVGP, CWVXV, CVWXT, CVWXV, CVWXW, CWHFF, and CWNDS.
| Brand | UCB Biosciences Inc. |
|---|---|
| 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 | Lack of Assurance of Sterility |
| Severity | moderate |
| Units affected | 141708 |
| Distribution | US Nationwide. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use recalled Cimzia from affected lots.
- Check your Cimzia cartons for the listed lot numbers and expiration dates; if matched, stop using and contact your healthcare provider or the manufacturer for instructions.
- If you have used recalled product or experience symptoms, contact your prescriber promptly for guidance.
- For more information, contact UCB Biosciences or the FDA recall information line.
How to identify the recalled item
| Lot / date codes | 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. |
|---|---|
| Lot / date codes | 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. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.