Quick answers
- What is Furosemide used for?
- The FDA-approved label (Lasix, Validus Pharmaceuticals LLC, September 30, 2025) says: “Edema LASIX is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. LASIX is particularly useful when an agent with greater diuretic potential is desired. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Furosemide have a boxed warning?
- The label we quote has no boxed warning, but 22 of 143 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Furosemide?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 27, 2026). Ask your pharmacist about alternatives.
- Has Furosemide been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started March 20, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Furosemide?
- 59 companies list prescription products of Furosemide in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Hikma Pharmaceuticals USA Inc..
What Furosemide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Edema LASIX is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. LASIX is particularly useful when an agent with greater diuretic potential is desired. …
— FDA label: Lasix, Validus Pharmaceuticals LLC, effective September 30, 2025. Read the full label on DailyMed →
The FDA has 143 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.
22 of 143 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection, solution · Injection · Solution |
|---|---|
| Route | Oral · Intravenous · Intramuscular · Subcutaneous |
| Prescription products | 217 in the FDA NDC Directory |
| Brand names | Lasix, Furoscix, Lasix Onyu |
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 |
|---|---|---|
| furosemide 10 mg/mL injection | Generic | $0.2646–$0.5291 per mL 4 packages, lowest to highest |
| furosemide 10 mg/mL injection, solution | Generic | $0.2646–$0.5291 per mL 28 packages, lowest to highest |
| furosemide 10 mg/mL solution | Generic | $0.0934 per mL |
| furosemide 20 mg tablet | Generic | $0.0249 per tablet |
| furosemide 20 mg tablet | Brand: Lasix | $0.7487 per tablet |
| furosemide 20 mg/2 mL injection, solution | Generic | $0.5291 per mL |
| furosemide 40 mg tablet | Generic | $0.0288 per tablet |
| furosemide 40 mg tablet | Brand: Lasix | $1.05 per tablet |
| furosemide 40 mg/4 mL injection, solution | Generic | $0.2646 per mL |
| furosemide 40 mg/4 mL solution | Generic | $0.0934 per mL |
| furosemide 80 mg tablet | Generic | $0.0498 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.
- A-S Medication Solutions16 products
- Bryant Ranch Prepack14 products
- Hikma Pharmaceuticals USA Inc.13 products
- Medical Purchasing Solutions, LLC9 products
- NuCare Pharmaceuticals, Inc.9 products
- Aphena Pharma Solutions - Tennessee, LLC9 products
- Remedyrepack Inc.8 products
- HF Acquisition Co LLC, DBA HealthFirst8 products
- PD-Rx Pharmaceuticals, Inc.7 products
- Cardinal Health 107, LLC7 products
- Baxter Healthcare Corporation6 products
- Northwind Health Company, LLC5 products
- Proficient Rx LP4 products
- Coupler LLC4 products
- Accord Healthcare Inc.3 products
- Preferred Pharmaceuticals Inc.3 products
- Leading Pharma, LLC3 products
- Lifestar Pharma LLC3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Ipca Laboratories Limited3 products
- Marlex Pharmaceuticals, Inc.3 products
- Validus Pharmaceuticals LLC3 products
- AvKARE3 products
- Micro Labs Limited3 products
- Aurobindo Pharma Limited3 products
- Granulation Technology, Inc.3 products
- Gland Pharma Limited3 products
- Solco Healthcare LLC3 products
- Rising Pharma Holdings, Inc.3 products
- NorthStar Rx LLC3 products
- Devatis, Inc.3 products
- Henry Schein, Inc.3 products
- Maiva Pharma Private Limited3 products
- Camber Pharmaceuticals, Inc.3 products
- Eugia US LLC3 products
- Redpharm Drug3 products
- ProPharma Distribution2 products
- Amneal Pharmaceuticals LLC2 products
- Sagent Pharmaceuticals2 products
- Chartwell RX, LLC2 products
- Calvin Scott & Co., Inc.2 products
- Precision Dose, Inc.2 products
- Meitheal Pharmaceuticals Inc.2 products
- Major Pharmaceuticals2 products
- Direct_Rx2 products
- Civica, Inc.2 products
- Hospira, Inc.2 products
- scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation2 products
- Fresenius Kabi USA, LLC2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- QPharma, Inc.1 product
- Unit Dose Solutions, Inc.1 product
- Phlow Corporation1 product
- Atlantic Biologicals Corps1 product
- St. Mary's Medical Park Pharmacy1 product
- SQ Innovation, Inc.1 product
- Avenacy Inc.1 product
- Prefferred Pharmaceuticals Inc.1 product
- Atlantic Biologicals Corp.1 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 |
|---|---|---|---|
| NDA016273 LASIX | Validus Pharms | July 1, 1966 | 36, latest August 8, 2018 2018: Labeling · 2016: Labeling · 2012: Labeling |
| NDA018267 FUROSEMIDE | Hikma | May 19, 1981 | 17, latest October 1, 2024 2024: Labeling · 2023: Manufacturing (CMC) · 2001: Manufacturing (CMC) |
| NDA018413 FUROSEMIDE | Chartwell Rx | November 30, 1983 | 37, latest August 7, 2015 2015: Manufacturing (CMC) · 2012: Labeling · 2010: Labeling |
| NDA018569 FUROSEMIDE | Epic Pharma LLC | October 19, 1981 | 33, latest June 2, 2026 2026: Labeling · 2020: Labeling · 2016: Labeling |
| NDA018667 FUROSEMIDE | Hospira | May 28, 1982 | 18, latest October 1, 2024 2024: Labeling · 2022: Labeling · 2016: Labeling |
| NDA018823 FUROSEMIDE | Hikma | November 10, 1983 | 34, latest July 14, 2017 2017: Labeling · 2012: Labeling · 2011: Labeling |
| NDA018902 FUROSEMIDE | Fresenius Kabi USA | May 22, 1984 | 20, latest October 1, 2024 2024: Labeling · 2023: Labeling · 2022: Labeling |
| NDA209988 FUROSCIX, FUROSCIX READYFLOW (AUTOINJECTOR) | Scpharmaceuticals | October 7, 2022 | 4, latest July 23, 2026 2026: Efficacy · 2025: Efficacy · 2025: Efficacy |
| NDA217294 LASIX ONYU | Sq Innovation | October 7, 2025 | — |
Generic approvals (20)
- ANDA070086Hikma · January 24, 1986
- ANDA070017Accord Hlthcare · December 15, 1986
- ANDA070433Hikma · April 22, 1987
- ANDA070434Hikma · April 22, 1987
- ANDA076796Prinston Inc · March 26, 2004
- ANDA077293Leading · November 9, 2005
- ANDA078010Ipca Labs Ltd · September 18, 2006
- ANDA202747Baxter Hlthcare Corp · January 27, 2014
- ANDA203428Avet Lifesciences · August 26, 2014
- ANDA207552Amneal Pharms Co · July 20, 2016
- ANDA212174Eugia Pharma · May 3, 2019
- ANDA213902Gland · July 1, 2020
- ANDA214766Sagent · January 27, 2021
- ANDA212803Meitheal · January 27, 2022
- ANDA216629Graviti Pharms · October 17, 2022
- ANDA216860Mankind Pharma · December 16, 2022
- ANDA215856Saba Ilac Sanayive · April 2, 2024
- ANDA217557Aspiro · December 13, 2024
- ANDA218831Aurobindo Pharma Ltd · July 17, 2025
- ANDA218188Micro Labs · January 8, 2026
Shortage status
Current shortage · updated October 27, 2026 · first posted March 31, 2026
| Product | Furosemide, Oral Solution, 10 mg/1 mL (NDC 0054-3294-46) |
|---|---|
| Availability | Available |
| Company | Hikma Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
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 20, 2026 · Class II · Ongoing · D-0486-2026
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01 — Leading Pharma, LLC
-
January 10, 2026 · Class II · Ongoing · D-0293-2026
Presence of Foreign Substance
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563- — Graviti Pharmaceuticals Private Limited
-
December 22, 2016 · Class II · Terminated · D-0437-2017
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31. — Roxane Laboratories, Inc.
-
September 25, 2015 · Class III · Terminated · D-0011-2016
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8. — Boehringer Ingelheim Roxane Inc
-
September 25, 2015 · Class III · Terminated · D-0012-2016
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2. — Boehringer Ingelheim Roxane Inc
-
February 26, 2013 · Class II · Terminated · D-314-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04 — Hospira Inc.
-
January 10, 2013 · Class II · Terminated · D-169-2013
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04 — 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
| RxCUI (RxNorm) | 197730, 197731, 197732, 200801, 200809, 205732, 310429, 313988, 1719286, 1719290 … (+9) |
|---|---|
| SPL set ID of the quoted label | 2c9b4d8f-0770-482d-a9e6-9c616a440b1a |
| FDA labels (SPL) | 143 |
| FDA applications | NDA016273, NDA018267, NDA018413, NDA018569, NDA018667, NDA018823, NDA018902, NDA209988, NDA217294, 20 ANDA |
| Active ingredients (FDA) | FUROSEMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lasix, Validus Pharmaceuticals LLC, effective September 30, 2025; 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 →