{"url_path":"/fda/drug/recalls/D-0546-2026","section_key":"summary","section_title":"DRUG Recall: UCB Biosciences Inc. — 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.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-05-08","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0546-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"UCB Biosciences Inc."},"word_count":102,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0546-2026\n\n**Recalling firm:** UCB Biosciences Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-08\n**Report date:** 2026-05-27\n\n## Product\ncimzia (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.\n\n## Reason\nLack of Assurance of Sterility\n\n## Affected lots\nLot: 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.\n\n## Distribution\nUS Nationwide."}