Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Losartan potassium

Brand names: Losortan Potassium, Cozaar, Arbli

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
20Recalls (FDA reports)
42Companies
1995First FDA approval on file

Quick answers

What is Losartan potassium used for?
The FDA-approved label (Cozaar, Organon LLC, January 20, 2026) says: “COZAAR is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Losartan potassium have a boxed warning?
Yes. The FDA label for Cozaar has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Losartan potassium?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Losartan potassium been recalled?
FDA enforcement reports list 20 recalls of products of this medicine; the newest started June 26, 2023 (Class II). A recall usually concerns specific lots, not every product.
Who makes Losartan potassium?
42 companies list prescription products of Losartan potassium in the FDA NDC Directory, including Bryant Ranch Prepack, NuCare Pharmaceuticals, Inc. and A-S Medication Solutions.

What Losartan potassium is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

COZAAR is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. …

— FDA label: Cozaar, Organon LLC, effective January 20, 2026. Read the full label on DailyMed →

The FDA has 133 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.

Heart failureHigh blood pressureStroke

Related medical specialties

CardiologyNeurology

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: FETAL TOXICITY. Read it on the full label →

131 of 133 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Suspension
RouteOral
Prescription products207 in the FDA NDC Directory
Brand namesLosortan Potassium, Cozaar, Arbli

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.

NADAC per unit for Losartan potassium, by strength and form
Strength and formGeneric or brandPharmacies pay
losartan potassium 100 mg
tablet		 Generic $0.0449 per tablet
losartan potassium 100 mg
tablet, film coated		 Generic $0.0449 per tablet
losartan potassium 100 mg
tablet, film coated		 Brand: Cozaar $6.14 per tablet
losartan potassium 25 mg
tablet		 Generic $0.0223 per tablet
losartan potassium 25 mg
tablet, film coated		 Generic $0.0223 per tablet
losartan potassium 25 mg
tablet, film coated		 Brand: Cozaar $3.36 per tablet
losartan potassium 50 mg
tablet		 Generic $0.0332 per tablet
losartan potassium 50 mg
tablet, film coated		 Generic $0.0332 per tablet
losartan potassium 50 mg
tablet, film coated		 Brand: Cozaar $4.49 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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA020386
COZAAR		 OrganonApril 14, 1995 50, latest June 20, 2025
2025: Labeling · 2021: Labeling · 2018: Labeling
NDA218772
ARBLI		 ScientureMarch 13, 2025 1, latest February 18, 2026
2026: Labeling

Generic approvals (14)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. June 26, 2023 · Class II · Terminated · D-0895-2023

    Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

    Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipur — Strides Pharma Inc.

  2. June 6, 2022 · Class II · Terminated · D-1161-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, — PD-Rx Pharmaceuticals, Inc.

  3. June 6, 2022 · Class II · Terminated · D-1162-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, — PD-Rx Pharmaceuticals, Inc.

  4. June 6, 2022 · Class II · Terminated · D-1163-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102 — PD-Rx Pharmaceuticals, Inc.

  5. May 18, 2022 · Class II · Terminated · D-0973-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Dist — Strides Pharma Inc.

  6. May 18, 2022 · Class II · Terminated · D-0972-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distr — Strides Pharma Inc.

  7. May 18, 2022 · Class II · Terminated · D-0974-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Dis — Strides Pharma Inc.

  8. April 15, 2022 · Class II · Terminated · D-0832-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 — Macleods Pharma Usa Inc

  9. April 15, 2022 · Class II · Terminated · D-0834-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, — Macleods Pharma Usa Inc

  10. April 15, 2022 · Class II · Terminated · D-0833-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, — Macleods Pharma Usa Inc

  11. April 6, 2022 · Class II · Terminated · D-0788-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

    Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202. — RemedyRepack Inc.

  12. March 31, 2022 · Class II · Terminated · D-0840-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. — Lupin Pharmaceuticals Inc.

  13. March 31, 2022 · Class II · Terminated · D-0838-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. B — Lupin Pharmaceuticals Inc.

  14. March 31, 2022 · Class II · Terminated · D-0839-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. B — Lupin Pharmaceuticals Inc.

  15. June 20, 2019 · Class II · Terminated · D-1458-2019

    CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44 — Macleods Pharma Usa Inc

  16. June 20, 2019 · Class II · Terminated · D-1457-2019

    CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10 — Macleods Pharma Usa Inc

  17. March 8, 2019 · Class II · Terminated · D-0341-2021

    CGMP deviation: Product found to contain trace amounts of NMBA

    Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90 — PD-Rx Pharmaceuticals, Inc.

  18. February 28, 2019 · Class II · Ongoing · D-1043-2019

    CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

    Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 088 — Camber Pharmaceuticals Inc

  19. February 28, 2019 · Class II · Ongoing · D-1042-2019

    CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

    Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 0885 — Camber Pharmaceuticals Inc

  20. February 28, 2019 · Class II · Ongoing · D-1041-2019

    CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

    Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ — Camber Pharmaceuticals 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)979480, 979482, 979485, 979487, 979492, 979494, 2709039, 2709046
SPL set ID of the quoted label9949448f-c3b9-44ee-94ed-c1aca8c90f39
FDA labels (SPL)133
FDA applicationsNDA020386, NDA218772, 14 ANDA
Active ingredients (FDA)LOSARTAN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Cozaar, Organon LLC, effective January 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

Report an error → · Information for medicine makers