Quick answers
- What is Amphotericin b used for?
- The FDA-approved label (Amphotericin B, Sun Pharmaceutical Industries, Inc., April 20, 2026) says: “Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amphotericin b have a boxed warning?
- The label we quote has no boxed warning, but 1 of 5 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Amphotericin b?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amphotericin b been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 19, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Amphotericin b?
- 5 companies list prescription products of Amphotericin b in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., XGen Pharmaceuticals DJB, Inc. and Eugia US LLC.
What Amphotericin b is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES). …
— FDA label: Amphotericin B, Sun Pharmaceutical Industries, Inc., effective April 20, 2026. Read the full label on DailyMed →
The FDA has 5 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.
The label quoted above has no boxed warning.
1 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injectable, liposomal · Injection, powder, lyophilized, for solution · Injection, powder, lyophilized, for suspension |
|---|---|
| Route | Intravenous |
| Prescription products | 6 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.
- Sun Pharmaceutical Industries, Inc.2 products
- XGen Pharmaceuticals DJB, Inc.1 product
- Eugia US LLC1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Mylan Institutional LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA063206Xgen Pharms · April 29, 1992
- ANDA212514Spil · December 14, 2021
- ANDA214010Eugia Pharma · November 17, 2022
- ANDA215354Avet Lifesciences · June 2, 2025
- ANDA212967Mylan Labs Ltd · June 30, 2025
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.
-
April 19, 2024 · Class II · Ongoing · D-0493-2024
Out of specification for assay
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-3893 — SUN PHARMACEUTICAL INDUSTRIES 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) | 239240, 967385 |
|---|---|
| SPL set ID of the quoted label | 593cffa0-c305-48b6-8ec7-331e0ff91d2b |
| FDA labels (SPL) | 5 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | AMPHOTERICIN B |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amphotericin B, Sun Pharmaceutical Industries, Inc., effective April 20, 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 →