Quick answers
- What is Bleomycin used for?
- The FDA-approved label (Bleomycin, Meitheal Pharmaceuticals Inc., April 17, 2026) says: “Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous Cell Carcinoma …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bleomycin have a boxed warning?
- Yes. The FDA label for Bleomycin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Bleomycin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bleomycin been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started December 21, 2023 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Bleomycin?
- 5 companies list prescription products of Bleomycin in the FDA NDC Directory, including Hospira, Inc., Meitheal Pharmaceuticals Inc. and NorthStar Rx LLC.
What Bleomycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous Cell Carcinoma …
— FDA label: Bleomycin, Meitheal Pharmaceuticals Inc., effective April 17, 2026. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
6 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Powder, for solution |
|---|---|
| Route | Intramuscular · Intrapleural · Intravenous · Subcutaneous |
| Prescription products | 12 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| bleomycin sulfate 15 USP units injection, powder, lyophilized, for solution | Generic | $26.45 per unit |
| bleomycin sulfate 15 USP units powder, for solution | Generic | $26.45 per unit |
NADAC list of November 4, 2026; these prices took effect on April 22, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hospira, Inc.4 products
- Meitheal Pharmaceuticals Inc.2 products
- NorthStar Rx LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Fresenius Kabi USA, LLC2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA065031Hospira · March 10, 2000
- ANDA065042Hikma · October 17, 2001
- ANDA065185Fresenius Kabi USA · January 28, 2008
- ANDA205030Meitheal · April 20, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 21, 2023 · Class I · Ongoing · D-0261-2024
Presence of particulate matter: glass
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18 — PFIZER
-
August 5, 2021 · Class III · Terminated · D-0771-2021
Labeling: Not elsewhere classified: Mislabeling
Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, — Hikma Pharmaceuticals USA Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1726673, 1726676 |
|---|---|
| SPL set ID of the quoted label | 640602f9-a7df-46f0-a9b1-19c471008bee |
| FDA labels (SPL) | 6 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | BLEOMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Bleomycin, Meitheal Pharmaceuticals Inc., effective April 17, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →