Why it was recalled
Lack of Assurance of Sterility
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 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.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0546-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 8, 2026
- FDA report date
- May 27, 2026
- Quantity
- 141,708 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- UCB Biosciences Inc.
Original FDA data
Every field from FDA enforcement report D-0546-2026, exactly as published.
Show all FDA fields
- City
- Smyrna
- State
- GA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98915
- Address
- 1950 Lake Park Dr SE
- Code information
- Lot: 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.
- Postal code
- 30080-7648
- Report date
- May 27, 2026
- Product type
- Drugs
- Recall number
- D-0546-2026
- Classification
- Class II
- Recalling firm
- UCB Biosciences Inc.
- Product quantity
- 141,708 cartons
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- May 8, 2026
- Initial firm notification
- Letter
- Center classification date
- May 20, 2026