Tumor Necrosis Factor Blocker
Where is Infliximab made?
6 companies sell it under their own name. Their labels name 6 factories in the United States, Switzerland, the Netherlands and Italy.
United States 3Switzerland 1Netherlands 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Biotech, Inc. Remicade100 mg per 10 mL · NDC 57894-030, 57894-160 | Cilag AGMakes it, tests it and packages it | Schaffhausen, Switzerland | No problems foundNov 2025 |
| Hospira, Inc.Makes it and tests it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 | |
| Janssen Biologics B.V.Makes the active ingredient and tests it | Leiden, Netherlands | Problems found, fixed voluntarilyJun 2023 | |
| Janssen Biotech, Inc.Makes the active ingredient and tests it | Malvern, PA, United States | Problems found, fixed voluntarilyJul 2025 | |
| Janssen-Cilag Manufacturing, LLCMakes it and tests it | Gurabo, PR, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Patheon Italia S.p.A.Makes it and tests it | Monza, Italy | Problems found, fixed voluntarilyMay 2023 | |
| Amgen Inc Avsola100 mg per 10 mL · NDC 55513-670 | The label doesn't name the factory. Plants this company names for other drugs | ||
| CELLTRION USA, Inc. Zymfentra120 mg per 1 mL · NDC 72606-047 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Merck Sharp & Dohme LLC Renflexis100 mg · NDC 0006-4305 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Organon LLC Renflexis100 mg · NDC 78206-162 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pfizer Laboratories Div Pfizer Inc Inflectra100 mg per 10 mL · NDC 0069-0809 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jan 17, 2025 · Class II · McKesson
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.