Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Biogen MA Inc. | Morrisville, NC, United States | Makes the active ingredient | No problems foundJun 13, 2018 · 9 inspections |
| Cilag AG | Schaffhausen, Switzerland | Makes it, tests it and packages it | No problems foundNov 21, 2025 · 8 inspections |
| Janssen Biotech, Inc. | Malvern, PA, United States | Makes the active ingredient | Problems found, fixed voluntarilyJul 29, 2025 · 13 inspections |
| Janssen Sciences Ireland UC | CO Cork, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJan 12, 2024 · 5 inspections |
| AndersonBrecon Inc. | Rockford, IL, United States | Packages it | No problems foundAug 19, 2026 · 11 inspections |
| Janssen Biologics B.V. | Leiden, Netherlands | Tests it | Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections |
| Janssen Pharmaceutica NV | Beerse, Belgium | Packages it and labels it | Problems found, fixed voluntarilySep 5, 2025 · 8 inspections |
| PPD Development Ireland Ltd. | Athlone, Ireland | Tests it | Problems found, fixed voluntarilyMar 9, 2023 · 4 inspections |
Recalls
- Mar 9, 2021 · Class III · Cardinal Health Inc.
Temperature Abuse
Lots: KESOY.AI Exp. 04/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Guselkumab: every company that makes it
- Form
- injection, subcutaneous
- Strength
- 100 mg per 1 mL
- Approval
- BLA BLA761061
- On the market since
- Jul 13, 2017
- Package NDCs
57894-640-0157894-640-0357894-640-0457894-640-0657894-640-1157894-640-99- Official label
- DailyMed (National Library of Medicine), updated Oct 20, 2026
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?