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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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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 ↗
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