Unrated Drug recall · FDA · Published May 8, 2026

UCB Cimzia Prefilled Syringes Recall: Lack of Sterility Assurance

UCB Biosciences recalls cimzia prefilled syringes due to lack of sterility assurance. These injectable medications may cause infections if used.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0546-2026Drug UCB Biosciences ›

Recall notice

Lack of Assurance of Sterility

Take action

Contact the company

Recalling firmUCB Biosciences Inc.1950 Lake Park Dr SE · Smyrna, GA 30080-7648

✎ GovInfoNow plain-language explainer

UCB Biosciences is recalling certain cimzia prefilled syringes because they lack sterility assurance. This could lead to infections if the medication is injected. Read more at govinfonow.com/recall/31315-ucb-cimzia-prefilled-syringes-recall-lack-of-sterility-assurance.

Source Summary by GovInfoNow · govinfonow.com/recall/31315-ucb-cimzia-prefilled-syringes-recall-lack-of-sterility-assurance · Updated August 17, 2026 · FDA enforcement record: FDA #D-0546-2026

Cite this page

“UCB Cimzia Prefilled Syringes Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31315-ucb-cimzia-prefilled-syringes-recall-lack-of-sterility-assurance. Based on FDA recall #D-0546-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0546-2026%22&limit=1).

The FDA announced on May 8, 2026, that UCB Biosciences Inc. is voluntarily recalling cimzia (certolizumab pegol) prefilled syringes due to a lack of assurance of sterility. The recall affects 141,708 cartons distributed nationwide.

How to tell if you have it

Brand: UCB Biosciences
Product: cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose)
NDCs: 50474-710-79, 50474-710-80, 50474-710-81
Lot codes: CVZFW, CVZYG, CWSYT, CWDZY, CWTSD, CVTFK, CVTSN, CWVGP, CVWXT, CVWXV, CVWXW, CWHFF, CWNDS
Expiration dates: 2026-JUL-04, 2026-AUG-19, 2026-OCT-22, 2026-NOV-20, 2026-DEC-11

The hazard

The recall is due to a lack of assurance of sterility. The FDA reported 116,499 adverse-event records in its FAERS database naming this product, including 75,177 serious cases and 6,589 deaths, though these are unverified reports not linked to this specific recall.

Context

GovInfoNow's records show other recent recalls of similar products include the Fresenius Kabi acyclovir injection recall (2026-02-05), the Fresenius Kabi 5% Dextrose Injection Recall (2026-03-11), and the New Life Pharma Semaglutide Injections Recall (2026-02-26).

How to tell if you have this one

Check for the product name 'cimzia' (certolizumab pegol), 2x200mg/mL prefilled syringes. Look for lot numbers CVZFW, CVZYG, CWSYT, CWDZY, CWTSD, CVTFK, CVTSN, CWVGP, CVWXT, CVWXV, CVWXW, CWHFF, CWNDS.

Brand
UCB Biosciences
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot number and expiration date on the syringe packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 19 days after the firm started it.

May 8, 2026Firm started the recall
May 20, 2026FDA classified it Class II
May 27, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31315-ucb-cimzia-prefilled-syringes-recall-lack-of-sterility-assurance">UCB Cimzia Prefilled Syringes Recall: Lack of Sterility Assurance (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0546-2026 (May 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0546-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.