cimzia — Class II drug recall D-0546-2026
Ongoing recall by UCB Biosciences Inc., reported 2026-05-27, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0546-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | UCB Biosciences Inc., Smyrna, GA, United States |
| Recall initiated | 2026-05-08 |
| Classified | 2026-05-20 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 141,708 cartons |
| Reason classes | sterility |
| NDC | 50474-0700, 50474-0700-61, 50474-0700-62, 50474-0710, 50474-0710-79, 50474-0710-80, 50474-0710-81, 50474-0750, 50474-0750-10 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0546-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.