Quick answers
- What is Polymyxin b sulfate used for?
- The FDA-approved label (Polymyxin B, Xellia Pharmaceuticals USA LLC, June 22, 2026) says: “Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa. Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and blood-stream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Polymyxin b sulfate have a boxed warning?
- Yes. The FDA label for Polymyxin B has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Polymyxin b sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Polymyxin b sulfate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started January 26, 2022 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Polymyxin b sulfate?
- 7 companies list prescription products of Polymyxin b sulfate in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc. and Gland Pharma Limited.
What Polymyxin b sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa. Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and blood-stream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. …
— FDA label: Polymyxin B, Xellia Pharmaceuticals USA LLC, effective June 22, 2026. Read the full label on DailyMed →
The FDA has 10 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 →
10 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection, powder, for solution |
|---|---|
| Route | Intramuscular · Intrathecal · Intravenous · Ophthalmic |
| Prescription products | 9 in the FDA NDC Directory |
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.
- Fresenius Kabi USA, LLC3 products
- Hikma Pharmaceuticals USA Inc.2 products
- Gland Pharma Limited1 product
- Fosun Pharma USA Inc.1 product
- Sagent Pharmaceuticals1 product
- Eugia US LLC1 product
- Xellia Pharmaceuticals USA LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA060716Hikma · June 29, 1964
- ANDA065372Fresenius Kabi USA · January 10, 2008
- ANDA202766Xellia Pharms Aps · January 15, 2014
- ANDA206589Eugia Pharma · April 4, 2016
- ANDA207322Gland · April 14, 2016
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.
-
January 26, 2022 · Class I · Terminated · D-0556-2022
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10 — AuroMedics Pharma LLC
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) | 204509 |
|---|---|
| SPL set ID of the quoted label | b56f18c0-ef5e-4ed9-a5af-f79f3cd189b6 |
| FDA labels (SPL) | 10 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | POLYMYXIN B |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Polymyxin B, Xellia Pharmaceuticals USA LLC, effective June 22, 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 →