UCB, Inc.
NDC labeler codes: 0131, 43376, 50474
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- LevetiracetamKeppra, Spritam, Keppra XR · 8 products
- BrivaracetamBriviact · 7 products
- LacosamideVimpat, Motpoly XR · 6 products
- RotigotineNeupro · 6 products
- BimekizumabBimzelx · 4 products
- RozanolixizumabRystiggo · 4 products
- ZilucoplanZilbrysq · 3 products
- Certolizumab pegolCimzia · 2 products
- MidazolamNayzilam · 1 product
- Doxecitine and doxribtimineKygevvi · 1 product
- FenfluramineFintepla · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| November 3, 2025 | NDA219792 | Doxecitine and doxribtimine KYGEVVI | Ucb Inc |
| October 17, 2023 | BLA761151 | Bimekizumab BIMZELX | Ucb Inc |
| October 17, 2023 | NDA216834 | Zilucoplan ZILBRYSQ | Ucb Inc |
| June 26, 2023 | BLA761286 | Rozanolixizumab RYSTIGGO | Ucb Inc |
| June 25, 2020 | NDA212102 | Fenfluramine FINTEPLA | Ucb Inc |
| May 17, 2019 | NDA211321 | Midazolam NAYZILAM | Ucb Inc |
| February 18, 2016 | NDA205836 | Brivaracetam BRIVIACT | Ucb Inc |
| February 18, 2016 | NDA205837 | Brivaracetam BRIVIACT | Ucb Inc |
| February 18, 2016 | NDA205838 | Brivaracetam BRIVIACT | Ucb Inc |
| April 20, 2010 | NDA022255 | Lacosamide VIMPAT | Ucb Inc |
| October 28, 2008 | NDA022253 | Lacosamide VIMPAT | Ucb Inc |
| October 28, 2008 | NDA022254 | Lacosamide VIMPAT | Ucb Inc |
| September 12, 2008 | NDA022285 | Levetiracetam KEPPRA XR | Ucb Inc |
| April 22, 2008 | BLA125160 | Certolizumab pegol CIMZIA | Ucb Inc |
| May 9, 2007 | NDA021829 | Rotigotine NEUPRO | Ucb Inc |
| July 31, 2006 | NDA021872 | Levetiracetam KEPPRA | Ucb Inc |
| July 15, 2003 | NDA021505 | Levetiracetam KEPPRA | Ucb Inc |
| November 30, 1999 | NDA021035 | Levetiracetam KEPPRA | Ucb Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
May 8, 2026 · Class II · Ongoing · D-0546-2026 · Certolizumab pegol
Lack of Assurance of Sterility
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,
2021
-
March 15, 2021 · Class II · Terminated · D-0590-2021 · Lacosamide
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35
-
March 15, 2021 · Class II · Terminated · D-0591-2021 · Brivaracetam
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66
2019
-
July 18, 2019 · Class II · Terminated · D-1838-2019 · Levetiracetam
Failed Dissolution Specifications.
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026