Quick answers
- What is Levofloxacin used for?
- The FDA-approved label (Levofloxacin, Redpharm Drug, September 1, 2026) says: “Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1, 12.4 ). Pneumonia: Nosocomial and Community Acquired ( 1.2, 1.3 ) Skin and Skin Structure Infections (SSSI) …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levofloxacin have a boxed warning?
- Yes. The FDA label for Levofloxacin has a boxed warning (“WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Levofloxacin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levofloxacin been recalled?
- FDA enforcement reports list 11 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Levofloxacin?
- 41 companies list prescription products of Levofloxacin in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., Remedyrepack Inc. and A-S Medication Solutions.
What Levofloxacin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1, 12.4 ). Pneumonia: Nosocomial and Community Acquired ( 1.2, 1.3 ) Skin and Skin Structure Infections (SSSI) …
— FDA label: Levofloxacin, Redpharm Drug, effective September 1, 2026. Read the full label on DailyMed →
The FDA has 76 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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. Its heading: WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
. Read it on the full label →
72 of 76 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Injection, solution · Tablet · Solution · Injection, solution, concentrate · Solution/ drops · Injection |
|---|---|
| Route | Oral · Intravenous · Ophthalmic |
| Prescription products | 124 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 |
|---|---|---|
| levofloxacin 25 mg/mL solution | Generic | $1.33–$2.05 per mL 4 packages, lowest to highest |
| levofloxacin 250 mg tablet | Generic | $0.1102 per tablet |
| levofloxacin 250 mg tablet, film coated | Generic | $0.1102 per tablet |
| levofloxacin 500 mg tablet | Generic | $0.1352 per tablet |
| levofloxacin 500 mg tablet, film coated | Generic | $0.1352 per tablet |
| levofloxacin 750 mg tablet | Generic | $0.2609 per tablet |
| levofloxacin 750 mg tablet, film coated | Generic | $0.2609 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.
- NuCare Pharmaceuticals, Inc.7 products
- Remedyrepack Inc.7 products
- A-S Medication Solutions6 products
- PD-Rx Pharmaceuticals, Inc.6 products
- Hikma Pharmaceuticals USA Inc.6 products
- Bryant Ranch Prepack6 products
- Eugia US LLC5 products
- Redpharm Drug5 products
- Gland Pharma Limited5 products
- Preferred Pharmaceuticals Inc.4 products
- Hospira, Inc.3 products
- Hawaii Repack, Inc.3 products
- Camber Pharmaceuticals, Inc.3 products
- Golden State Medical Supply, Inc.3 products
- Aurobindo Pharma Limited3 products
- Viona Pharmaceuticals Inc3 products
- Macleods Pharmaceuticals Limited3 products
- Chartwell RX, LLC3 products
- Northwind Health Company, LLC3 products
- Proficient Rx LP3 products
- Zydus Lifesciences Limited3 products
- Asclemed USA, Inc.3 products
- Major Pharmaceuticals3 products
- WG Critical Care, LLC3 products
- Lupin Pharmaceuticals, Inc.3 products
- Dr. Reddy's Laboratories Limited3 products
- Coupler LLC2 products
- Cardinal Health 107, LLC2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Advanced Rx of Tennessee, LLC2 products
- Sagent Pharmaceuticals1 product
- BPI Labs LLC1 product
- Direct_Rx1 product
- Lannett Company, LLC1 product
- Verityrx, LLC1 product
- St. Mary's Medical Park Pharmacy1 product
- ANI Pharmaceuticals, Inc.1 product
- DirectRx1 product
- Advagen Pharma Limited1 product
- Baxter Healthcare Corporation1 product
- Fresenius Kabi USA, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (19)
- ANDA078282Rubicon Research · December 20, 2010
- ANDA076710DR Reddys Labs Inc · June 20, 2011
- ANDA078424Lupin · June 20, 2011
- ANDA091678Novitium Pharma · June 20, 2011
- ANDA201043Aurobindo Pharma Ltd · June 20, 2011
- ANDA090343Inforlife · July 7, 2011
- ANDA091375Hikma Farmaceutica · September 16, 2011
- ANDA200839Macleods Pharms Ltd · March 22, 2012
- ANDA076890Chartwell Molecular · March 30, 2012
- ANDA077652Zydus Lifesciences · September 7, 2012
- ANDA202328Eugia Pharma · January 24, 2013
- ANDA091436Baxter Hlthcare Corp · June 5, 2013
- ANDA200674Fresenius Kabi USA · June 19, 2013
- ANDA202801Hetero Labs Ltd V · January 8, 2015
- ANDA206919Eugia Pharma · February 10, 2016
- ANDA205222Lannett Co Inc · May 25, 2018
- ANDA205600Micro Labs Ltd India · February 27, 2019
- ANDA205540Gland · April 22, 2020
- ANDA206908Gland · December 30, 2020
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 13, 2022 · Class II · Terminated · D-1088-2022
cGMP deviations: Temperature abuse
Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61 — Mckesson Medical-Surgical Inc. Corporate Office
-
March 15, 2021 · Class II · Terminated · D-0494-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA — Cardinal Health Inc.
-
September 25, 2018 · Class III · Terminated · D-1215-2018
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., Nor — Baxter Healthcare Corporation
-
August 1, 2018 · Class III · Terminated · D-1034-2018
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables — Baxter Healthcare Corporation
-
August 1, 2018 · Class III · Terminated · D-1036-2018
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectabl — Baxter Healthcare Corporation
-
August 1, 2018 · Class III · Terminated · D-1035-2018
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectabl — Baxter Healthcare Corporation
-
March 27, 2018 · Class II · Terminated · D-0709-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured f — AuroMedics Pharma LLC
-
March 27, 2018 · Class II · Terminated · D-0708-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured f — AuroMedics Pharma LLC
-
March 27, 2018 · Class II · Terminated · D-0704-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured fo — AuroMedics Pharma LLC
-
January 12, 2018 · Class I · Terminated · D-0574-2018
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma L — AuroMedics Pharma LLC
-
March 10, 2017 · Class II · Terminated · D-0615-2017
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24 — Claris Lifesciences 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) — Levofloxacin, Redpharm Drug, effective September 1, 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 →