Quick answers
- What is Doxil?
- Doxil is a brand name of Doxorubicin hydrochloride, a prescription medicine. The FDA NDC Directory lists 4 Doxil products in 2 strengths and forms.
- Who makes Doxil?
- Baxter Hlthcare Corp holds the FDA application for Doxil (NDA050718, approved November 17, 1995). 1 other company (repackagers or distributors) also list Doxil products.
- Is there a generic or store brand of Doxil?
- Yes. The FDA NDC Directory lists 32 other products with the same active ingredients, strength and form as a Doxil product, 32 of them generic. Ask your pharmacist whether one is right for you.
- Has Doxil been recalled?
- FDA enforcement reports list 1 recall of Doxil products; the newest started August 24, 2023. A recall usually concerns specific lots, not every product.
What Doxil is
Each Doxil 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.
Doxorubicin hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| doxorubicin hydrochloride 2 mg/mL injection, suspension, liposomal (intravitreal) | Doxil | 16 products, 8 companies | DailyMed |
| doxorubicin hydrochloride 2 mg/mL injection, suspension, liposomal (intravenous) | Doxil | 16 products, 8 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Doxorubicin hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA050718 | Baxter Hlthcare Corp | November 17, 1995 | 4 |
Companies that list Doxil
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Doxil products.
- Baxter Healthcare Company2 products
- Baxter Healthcare Corporation2 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.
-
August 24, 2023 · Class II · Terminated · D-0048-2024
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01 — Baxter Healthcare Corporation
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.