Quick answers
- What is Linezolid used for?
- The FDA-approved label (Zyvox, Pharmacia & Upjohn Company LLC, July 9, 2026) says: “ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis; Uncomplicated skin and skin structure infections …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Linezolid have a boxed warning?
- No. None of the 35 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Linezolid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Linezolid been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 27, 2018 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Linezolid?
- 26 companies list prescription products of Linezolid in the FDA NDC Directory, including Pharmacia & Upjohn Company LLC, Hp Halden Pharma AS and Sportpharm LLC.
What Linezolid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis; Uncomplicated skin and skin structure infections …
— FDA label: Zyvox, Pharmacia & Upjohn Company LLC, effective July 9, 2026. Read the full label on DailyMed →
The FDA has 35 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.
The label quoted above has no boxed warning.
0 of 35 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Tablet, film coated · Tablet · Granule, for suspension · Injection · Powder, for suspension · Suspension · Tablet, coated |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 40 in the FDA NDC Directory |
| Brand names | Zyvox |
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 |
|---|---|---|
| linezolid 100 mg/5 mL granule, for suspension | Generic | $2.85 per mL |
| linezolid 100 mg/5 mL powder, for suspension | Generic | $2.85 per mL |
| linezolid 100 mg/5 mL suspension | Generic | $2.85 per mL |
| linezolid 600 mg tablet | Generic | $1.47 per tablet |
| linezolid 600 mg tablet, film coated | Generic | $1.47 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.
- Pharmacia & Upjohn Company LLC4 products
- Hp Halden Pharma AS4 products
- Sportpharm LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- American Health Packaging2 products
- Camber Pharmaceuticals, Inc.2 products
- Piramal Critical Care Inc2 products
- Bryant Ranch Prepack2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Sandoz Inc2 products
- Caplin Steriles Limited1 product
- Coupler LLC1 product
- Eugia US LLC1 product
- Fresenius Kabi USA, LLC1 product
- Remedyrepack Inc.1 product
- Hospira, Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- Major Pharmaceuticals1 product
- Alembic Pharmaceuticals Limited1 product
- Chartwell RX, LLC1 product
- Rising Pharma Holdings, Inc.1 product
- Lupin Pharmaceuticals, Inc.1 product
- A-S Medication Solutions1 product
- Macleods Pharmaceuticals Limited1 product
- Alembic Pharmaceuticals Inc.1 product
- Ascend Laboratories, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021130 ZYVOX | Pfizer | April 18, 2000 | 37, latest October 21, 2026 2026: Labeling · 2026: Labeling · 2024: Labeling |
| NDA021131 ZYVOX | Pfizer | April 18, 2000 | 35, latest October 21, 2026 2026: Labeling · 2026: Labeling · 2024: Labeling |
| NDA021132 ZYVOX | Pfizer | April 18, 2000 | 35, latest October 21, 2026 2026: Labeling · 2026: Labeling · 2024: Labeling |
| NDA206473 LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Hospira | June 18, 2015 | 9, latest June 9, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
Generic approvals (16)
- ANDA200068Hikma · June 3, 2015
- ANDA200904Sandoz · July 16, 2015
- ANDA078845Rising · December 21, 2015
- ANDA204239Hetero Labs Ltd V · December 21, 2015
- ANDA205233Alembic · December 21, 2015
- ANDA205517Alkem Labs Ltd · December 21, 2015
- ANDA204764Fresenius Kabi USA · March 15, 2016
- ANDA206917Eugia Pharma · August 4, 2016
- ANDA207526Novel Labs Inc · August 22, 2016
- ANDA207354Nang Kuang Pharm Co · December 20, 2016
- ANDA207001Hq Spclt Pharma · July 7, 2017
- ANDA210702Chartwell Rx · April 25, 2019
- ANDA206454Hikma · August 22, 2022
- ANDA211813Hetero Labs · October 31, 2022
- ANDA210378Macleods Pharms · October 10, 2024
- ANDA219558Caplin · December 8, 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.
-
March 27, 2018 · Class II · Terminated · D-0703-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242- — AuroMedics Pharma LLC
-
December 20, 2017 · Class I · Terminated · D-0337-2018
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51 — AuroMedics Pharma LLC
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) — Zyvox, Pharmacia & Upjohn Company LLC, effective July 9, 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 →