Quick answers
- What is Granix?
- Granix is a brand name of Filgrastim, a prescription medicine. The FDA NDC Directory lists 4 Granix products in 4 strengths and forms.
- Who makes Granix?
- Sicor Biotech holds the FDA application for Granix (BLA125294, approved August 29, 2012).
- Is there a generic or store brand of Granix?
- Yes. The FDA NDC Directory lists 16 other products with the same active ingredients, strength and form as a Granix product. Ask your pharmacist whether one is right for you.
- Has Granix been recalled?
- FDA enforcement reports list 1 recall of Granix products; the newest started January 10, 2025. A recall usually concerns specific lots, not every product.
What Granix is
Each Granix 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.
Filgrastim · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| filgrastim 300 ug/0.5 mL injection, solution (subcutaneous) | Granix | 5 products, 5 companies | — |
| filgrastim 300 ug/mL injection, solution (subcutaneous) | Granix | 3 products, 3 companies | — |
| filgrastim 480 ug/0.8 mL injection, solution (subcutaneous) | Granix | 5 products, 5 companies | — |
| filgrastim 480 ug/1.6 mL injection, solution (subcutaneous) | Granix | 3 products, 3 companies | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Filgrastim →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA125294 | Sicor Biotech | August 29, 2012 | 4 |
Companies that list Granix
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Granix products.
- Cephalon, LLC4 products
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 10, 2025 · Class II · Ongoing · D-0218-2025
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC — Teva Pharmaceuticals USA, Inc
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.