Quick answers
- What is Gentamicin sulfate used for?
- The FDA-approved label (Gentak, Proficient Rx LP, November 1, 2019) says: “Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gentamicin sulfate have a boxed warning?
- The label we quote has no boxed warning, but 18 of 39 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Gentamicin sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gentamicin sulfate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started May 29, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Gentamicin sulfate?
- 21 companies list prescription products of Gentamicin sulfate in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Proficient Rx LP and Baxter Healthcare Corporation.
What Gentamicin sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms …
— FDA label: Gentak, Proficient Rx LP, effective November 1, 2019. Read the full label on DailyMed →
The FDA has 39 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.
18 of 39 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Solution/ drops · Ointment · Solution · Cream |
|---|---|
| Route | Intravenous · Intramuscular · Ophthalmic · Topical |
| Prescription products | 44 in the FDA NDC Directory |
| Brand names | Gentak |
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 |
|---|---|---|
| gentamicin sulfate 0.1% cream | Generic | $0.8943–$0.9004 per gram 4 packages, lowest to highest |
| gentamicin sulfate 0.1% ointment | Generic | $0.7378–$0.9400 per gram 4 packages, lowest to highest |
| gentamicin sulfate 3 mg/mL solution | Generic | $0.9073 per mL |
| gentamicin sulfate 3 mg/mL solution/ drops | Generic | $0.9073 per mL |
| gentamicin sulfate 40 mg/mL injection, solution | Generic | $1.26 per mL |
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.
- Fresenius Kabi USA, LLC6 products
- Proficient Rx LP5 products
- Baxter Healthcare Corporation5 products
- NuCare Pharmaceuticals, Inc.4 products
- Medical Purchasing Solutions, LLC3 products
- Eugia US LLC3 products
- Direct_Rx2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Henry Schein, Inc.2 products
- Padagis Israel Pharmaceuticals Ltd2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Asclemed USA, Inc.2 products
- Cosette Pharmaceuticals, Inc.2 products
- Hospira, Inc.1 product
- Bausch & Lomb Incorporated1 product
- Preferred Pharmaceuticals Inc.1 product
- Remedyrepack Inc.1 product
- A-S Medication Solutions1 product
- Sandoz Inc1 product
- Cardinal Health 107, LLC1 product
- Encube Ethicals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (16)
- ANDA062251Hikma · June 5, 1980
- ANDA062196Sandoz · July 2, 1980
- ANDA062307Padagis Us · May 15, 1981
- ANDA062351Padagis Us · February 18, 1982
- ANDA062373Baxter Hlthcare · September 7, 1982
- ANDA062366Fresenius Kabi USA · August 4, 1983
- ANDA062420Hospira · August 15, 1983
- ANDA062452Allergan · October 10, 1984
- ANDA064054Cosette Pharms Nc · April 29, 1994
- ANDA064056Cosette Pharms Nc · April 29, 1994
- ANDA064048Bausch and Lomb Inc · May 11, 1994
- ANDA064093Sciegen Pharms · August 31, 1995
- ANDA064163Pharmobedient · October 12, 2001
- ANDA209233Encube · December 31, 2018
- ANDA215236Eugia Pharma · January 8, 2024
- ANDA215237Eugia Pharma · January 8, 2024
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.
-
May 29, 2025 · Class II · Ongoing · D-0472-2025
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25 — Eugia US LLC
-
November 12, 2014 · Class II · Terminated · D-0290-2015
Defective Container: Vials may be missing stoppers.
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20 — Fresenius Kabi USA, LLC
-
May 2, 2013 · Class II · Terminated · D-686-2013
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA. — Hospira 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gentak, Proficient Rx LP, effective November 1, 2019; 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 →