Cimzia Recall Issued for Sterility Assurance
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UCB Biosciences Inc. is recalling 141,708 cartons of Cimzia (certolizumab pegol) prefilled syringes due to lack of assurance of sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drug.
What Happened
UCB Biosciences Inc. initiated a voluntary recall of Cimzia (certolizumab pegol) due to lack of assurance of sterility. The recall is classified as Class II by the FDA and affects products distributed nationwide.
Which Products Are Affected
The affected product is cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080. Specific NDCs include a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81. A total of 141,708 cartons are involved. Affected lots include: 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). Recall number D-0546-2026.
What You Should Do
Consumers should contact their healthcare provider or pharmacist regarding the recalled product.
Why This Matters
The nationwide recall involves over 141,000 cartons of a prescription drug used as a tumor necrosis factor blocker.
Source
FDA recall D-0546-2026, UCB Biosciences Inc., Smyrna, GA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,262 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.