Prescription medicine
Gentamicin Brand names: Gentak; first approved as Garamycin
Gentamicin (Garamycin) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 24 generic labelers, and pharmacies paid $1.30 per mL (Gentamicin 80 mg/2 mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the gentamicin FDA label on DailyMed (effective July 22, 2024, Bausch & Lomb Incorporated); the NDA 50039 record on Drugs@FDA; every gentamicin label on DailyMed.
Highlights of the record
FDA label of July 22, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumon
Forms and strengths
- 1 mg/g
- 3 mg/ml
- 3 mg/g
- 10 mg/ml
- 40 mg/ml
- 60 mg/50ml
- 80 mg/50ml
- 80 mg/100ml
- 100 mg/50ml
- 100 mg/100ml
Injection (solution); solution/ drops; ointment; solution; cream.
On the market
- Earliest approval on file
- June 19, 1970 Garamycin, Schering; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 42 first March 15, 1966; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 24 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.30 per mL Gentamicin 80 mg/2 mL vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2012 0 Class I among all firms' recalls; latest May 29, 2025; 17 more by firms not listed as its makers
- FAERS reports
- 15,709 through July 30, 2026
What is gentamicin used for?
From the label: indications and usageGentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
Conditions named in the indications of gentamicin's FDA labels, with every medicine labeled for each:
From other gentamicin labelsBacterial infections: INDICATIONS AND USAGE Gentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis …
FDA pharmacologic class: Aminoglycoside Antibacterial.
Source: FDA drug label (Gentamicin Sulfate), Bausch & Lomb Incorporated, effective July 22, 2024 (SPL set 41d01350-5c4b-42fc-be5f-986ceec02bd3), via openFDA; the full label on DailyMed
Is there a generic for gentamicin (Garamycin)?
The FDA approved the first generic gentamicin on March 15, 1966. 42 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists gentamicin from 24 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 1966 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for gentamicin (Garamycin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.30 per mL (Gentamicin 80 mg/2 mL vial), down 21% from $1.66 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Gentamicin 80 mg/2 mL vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Gentamicin 0.1% cream | Generic | $0.886 per gram | n/a | +3% |
| Gentamicin 0.1% ointment | Generic | $0.856 per gram | n/a | -3% |
| Gentamicin 0.3% eye drop | Generic | $0.790 per mL | n/a | +12% |
| Gentamicin 80 mg/2 mL vial | Generic | $1.30 per mL | $2.61 per vial | -21% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has gentamicin been recalled?
The FDA's Enforcement Report lists 26 recalls naming gentamicin since 2012: 0 Class I (the most serious), 26 Class II, 0 Class III; 4 still ongoing. 17 of them are by firms that FDA's NDC Directory does not list as a maker of gentamicin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 29, 2025 | Class II | Eugia US LLC | Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. |
| March 15, 2022 | Class II | Teligent Pharma, Inc. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
| March 16, 2020 | Class II | The Medicine Shoppe Pharmacy not a listed maker | Lack of Assurance of Sterility |
| July 22, 2019 | Class II | Wise Pharmacy not a listed maker | Lack of Processing Controls |
| April 2, 2019 | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderson … not a listed maker | Lack of sterility assurance. |
| February 22, 2019 | Class II | Akorn, Inc. | Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 … |
| October 8, 2018 | Class II | Akorn, Inc. | Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. |
| May 17, 2016 | Class II | Well Care Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the gentamicin label say about other medicines?
The gentamicin label names no other medicine on this site. The labels of 25 other medicines name gentamicin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name gentamicin
Source: FDA drug label (Gentamicin Sulfate), Bausch & Lomb Incorporated, effective July 22, 2024 (SPL set 41d01350-5c4b-42fc-be5f-986ceec02bd3), via openFDA; the full label on DailyMed
What do FAERS reports show for gentamicin?
The FDA Adverse Event Reporting System holds 15,709 reports that list gentamicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,829 are coded as a death and 7,428 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does gentamicin compare with medicines for the same use?
9 side-by-side pages set gentamicin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other aminoglycoside antibacterials
- the pharmacologic class, with prices and generics
- Gentamicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other