Quick answers
- What is Neomycin sulfate used for?
- The FDA-approved label (Neomycin Sulfate, Remedyrepack Inc., April 24, 2026) says: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets, USP and other antibacterial drugs, neomycin sulfate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Neomycin sulfate have a boxed warning?
- Yes. The FDA label for Neomycin Sulfate has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Neomycin sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Neomycin sulfate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started August 23, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Neomycin sulfate?
- 4 companies list prescription products of Neomycin sulfate in the FDA NDC Directory, including Solaris Pharma Corporation, Teva Pharmaceuticals USA, Inc. and Chartwell RX, LLC.
What Neomycin sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets, USP and other antibacterial drugs, neomycin sulfate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …
— FDA label: Neomycin Sulfate, Remedyrepack Inc., effective April 24, 2026. Read the full label on DailyMed →
The FDA has 4 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 →
4 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 4 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 |
|---|---|---|
| neomycin sulfate 500 mg tablet | Generic | $0.8529 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 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.
- Solaris Pharma Corporation1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Chartwell RX, LLC1 product
- Remedyrepack Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA060304Teva · September 2, 1964
- ANDA065220Amvika · July 28, 2006
- ANDA204435Chartwell Molecular · June 10, 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.
-
August 23, 2022 · Class II · Terminated · D-1473-2022
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01 — Teva Pharmaceuticals USA Inc
-
March 15, 2021 · Class II · Terminated · D-0574-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01 — Cardinal Health 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) | 866042 |
|---|---|
| SPL set ID of the quoted label | 461f62b9-b9ec-43f2-aee7-0895638105b8 |
| FDA labels (SPL) | 4 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | NEOMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Neomycin Sulfate, Remedyrepack Inc., effective April 24, 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 →