Quick answers
- What is Inflectra?
- Inflectra is a brand name of Infliximab, a prescription medicine. The FDA NDC Directory lists 1 Inflectra product in 1 strength and form.
- Who makes Inflectra?
- Celltrion Inc holds the FDA application for Inflectra (BLA125544, approved April 5, 2016).
- Is there a generic or store brand of Inflectra?
- Yes. The FDA NDC Directory lists 3 other products with the same active ingredients, strength and form as a Inflectra product. Ask your pharmacist whether one is right for you.
- Has Inflectra been recalled?
- FDA enforcement reports list 1 recall of Inflectra products; the newest started January 17, 2025. A recall usually concerns specific lots, not every product.
What Inflectra is
Each Inflectra product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Infliximab · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| infliximab 100 mg/10 mL injection, powder, lyophilized, for solution (intravenous) | Inflectra | 3 products, 2 companies | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Infliximab →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA125544 | Celltrion Inc | April 5, 2016 | 1 |
Companies that list Inflectra
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Inflectra products.
- Pfizer Laboratories Div Pfizer Inc1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 17, 2025 · Class II · Ongoing · D-0213-2025
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01 — McKesson
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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.