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Prescription medicine · generic available

Valsartan

Brand names: Diovan, Prexxartan

Drug class: Angiotensin 2 Receptor Blocker

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

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
To be discontinuedFDA shortage list
28Recalls (FDA reports)
37Companies
2001First FDA approval on file

Quick answers

What is Valsartan used for?
The FDA-approved label (Diovan, Novartis Pharmaceuticals Corporation, August 11, 2026) says: “Diovan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults Post-myocardial infarction, for the reduction of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Valsartan have a boxed warning?
Yes. The FDA label for Diovan 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 Valsartan?
The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated November 19, 2025). Ask your pharmacist about alternatives.
Has Valsartan been recalled?
FDA enforcement reports list 28 recalls of products of this medicine; the newest started August 4, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Valsartan?
37 companies list prescription products of Valsartan in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Camber Pharmaceuticals, Inc..

What Valsartan is used for

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

Diovan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults Post-myocardial infarction, for the reduction of …

— FDA label: Diovan, Novartis Pharmaceuticals Corporation, effective August 11, 2026. Read the full label on DailyMed →

The FDA has 61 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 →

59 of 61 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Solution
RouteOral
Prescription products145 in the FDA NDC Directory
Brand namesDiovan

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 Valsartan, by strength and form
Strength and formGeneric or brandPharmacies pay
valsartan 160 mg
tablet		 Generic $0.1057 per tablet
valsartan 160 mg
tablet		 Brand: Diovan $10.04 per tablet
valsartan 160 mg
tablet, film coated		 Generic $0.1057 per tablet
valsartan 320 mg
tablet		 Generic $0.1703 per tablet
valsartan 320 mg
tablet		 Brand: Diovan $12.69 per tablet
valsartan 320 mg
tablet, film coated		 Generic $0.1703 per tablet
valsartan 40 mg
tablet		 Generic $0.1000 per tablet
valsartan 40 mg
tablet		 Brand: Diovan $7.82 per tablet
valsartan 40 mg
tablet, film coated		 Generic $0.1000 per tablet
valsartan 80 mg
tablet		 Generic $0.0808 per tablet
valsartan 80 mg
tablet		 Brand: Diovan $9.33 per tablet
valsartan 80 mg
tablet, film coated		 Generic $0.0808 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
NDA021283
DIOVAN		 NovartisJuly 18, 2001 29, latest July 21, 2025
2025: Manufacturing (CMC) · 2021: Manufacturing (CMC) · 2021: Efficacy
NDA209139
PREXXARTAN		 Carmel BiosciencesDecember 19, 2017 1, latest September 22, 2026
2026: Labeling

Generic approvals (19)

Shortage status

To be discontinued · updated November 19, 2025 · first posted November 19, 2025

ProductValsartan, Tablet, 160 mg (NDC 0378-5814-77)
CompanyMylan Pharmaceuticals Inc., a Viatris Company

Ask your pharmacist whether your product is affected and what the options are.

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. August 4, 2026 · Class II · Ongoing · D-0746-2026

    Failed Dissolution Specifications

    Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34 — Novartis Pharmaceuticals Corporation

  2. March 15, 2021 · Class II · Terminated · D-0461-2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India — Cardinal Health Inc.

  3. December 31, 2018 · Class II · Ongoing · D-1038-2019

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90 — Aurobindo Pharma USA Inc.

  4. December 31, 2018 · Class II · Ongoing · D-0370-2019

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90. — Aurobindo Pharma USA Inc.

  5. December 31, 2018 · Class II · Ongoing · D-1039-2019

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90 — Aurobindo Pharma USA Inc.

  6. December 31, 2018 · Class II · Ongoing · D-1037-2019

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30 — Aurobindo Pharma USA Inc.

  7. December 31, 2018 · Class II · Ongoing · D-1035-2019

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90 — Aurobindo Pharma USA Inc.

  8. December 4, 2018 · Class II · Ongoing · D-0326-2019

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77. — Mylan Laboratories Limited, (Nashik FDF)

  9. December 4, 2018 · Class II · Ongoing · D-0327-2019

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77. — Mylan Laboratories Limited, (Nashik FDF)

  10. December 4, 2018 · Class II · Ongoing · D-0324-2019

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93. — Mylan Laboratories Limited, (Nashik FDF)

  11. December 4, 2018 · Class II · Ongoing · D-0325-2019

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77. — Mylan Laboratories Limited, (Nashik FDF)

  12. November 20, 2018 · Class II · Ongoing · D-0314-2019

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77. — Mylan Pharmaceuticals Inc.

  13. November 20, 2018 · Class II · Ongoing · D-0316-2019

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77. — Mylan Pharmaceuticals Inc.

  14. November 20, 2018 · Class II · Ongoing · D-0315-2019

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93. — Mylan Pharmaceuticals Inc.

  15. November 20, 2018 · Class II · Ongoing · D-0313-2019

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77. — Mylan Pharmaceuticals Inc.

  16. August 14, 2018 · Class III · Terminated · D-1104-2018

    Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

    Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90 — Jubilant Cadista Pharmaceuticals, Inc.

  17. August 14, 2018 · Class III · Terminated · D-1103-2018

    Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

    Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30 — Jubilant Cadista Pharmaceuticals, Inc.

  18. August 14, 2018 · Class III · Terminated · D-1105-2018

    Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

    Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90 — Jubilant Cadista Pharmaceuticals, Inc.

  19. August 8, 2018 · Class II · Completed · D-1113-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar — Hetero Labs Limited Unit V

  20. August 8, 2018 · Class II · Completed · D-1114-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob — Hetero Labs Limited Unit V

  21. August 8, 2018 · Class II · Completed · D-1116-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nag — Hetero Labs Limited Unit V

  22. August 8, 2018 · Class II · Completed · D-1115-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar — Hetero Labs Limited Unit V

  23. July 27, 2018 · Class II · Terminated · D-1029-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. — Bryant Ranch Prepack Inc.

  24. July 13, 2018 · Class II · Ongoing · D-0971-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranb — Prinston Pharmaceutical Inc

  25. July 13, 2018 · Class II · Ongoing · D-0969-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranb — Prinston Pharmaceutical Inc

Showing the newest 25 of 28.

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)349199, 349200, 349201, 349483, 351761, 351762, 352001, 352274, 1996254
SPL set ID of the quoted label5ddba454-f3e6-43c2-a7a6-58365d297213
FDA labels (SPL)61
FDA applicationsNDA021283, NDA209139, 19 ANDA
Active ingredients (FDA)VALSARTAN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Diovan, Novartis Pharmaceuticals Corporation, effective August 11, 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