Quick answers
- What is Lisinopril used for?
- The FDA-approved label (Zestril, Upsher-Smith Laboratories, LLC, January 2, 2025) says: “Zestril is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older Adjunct therapy for heart failure Treatment of Acute Myocardial Infarction 1.1 Hypertension Zestril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lisinopril have a boxed warning?
- Yes. The FDA label for Zestril 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 Lisinopril?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lisinopril been recalled?
- FDA enforcement reports list 10 recalls of products of this medicine; the newest started November 15, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Lisinopril?
- 34 companies list prescription products of Lisinopril in the FDA NDC Directory, including A-S Medication Solutions, NuCare Pharmaceuticals, Inc. and Aphena Pharma Solutions - Tennessee, LLC.
What Lisinopril is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Zestril is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older Adjunct therapy for heart failure Treatment of Acute Myocardial Infarction 1.1 Hypertension Zestril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. …
— FDA label: Zestril, Upsher-Smith Laboratories, LLC, effective January 2, 2025. Read the full label on DailyMed →
The FDA has 152 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: FETAL TOXICITY
. Read it on the full label →
152 of 152 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| lisinopril 1 mg/mL solution | Brand: Qbrelis | $4.49 per mL |
| lisinopril 10 mg tablet | Generic | $0.0180 per tablet |
| lisinopril 10 mg tablet | Brand: Zestril | $12.52 per tablet |
| lisinopril 2.5 mg tablet | Generic | $0.0139 per tablet |
| lisinopril 20 mg tablet | Generic | $0.0249 per tablet |
| lisinopril 30 mg tablet | Generic | $0.0507 per tablet |
| lisinopril 40 mg tablet | Generic | $0.0459 per tablet |
| lisinopril 5 mg tablet | Generic | $0.0144 per tablet |
NADAC list of November 4, 2026; these prices took effect between March 18, 2026 and 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 Solutions19 products
- NuCare Pharmaceuticals, Inc.19 products
- Aphena Pharma Solutions - Tennessee, LLC18 products
- Bryant Ranch Prepack14 products
- Proficient Rx LP14 products
- Remedyrepack Inc.13 products
- PD-Rx Pharmaceuticals, Inc.13 products
- Exelan Pharmaceuticals Inc.12 products
- Camber Pharmaceuticals, Inc.12 products
- Solco Healthcare U.S., LLC12 products
- Northwind Health Company, LLC12 products
- Lupin Pharmaceuticals, Inc.10 products
- QPharma, Inc.9 products
- Actavis Pharma, Inc.6 products
- BluePoint Laboratories6 products
- NCS HealthCare of KY, LLC dba Vangard Labs6 products
- Chartwell RX, LLC6 products
- XLCare Pharmaceuticals, Inc.6 products
- Asclemed USA, Inc.6 products
- Upsher-Smith Laboratories, LLC6 products
- Legacy Pharmaceutical Packaging, LLC6 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)6 products
- Aurobindo Pharma Limited6 products
- Quallent Pharmaceuticals Health LLC5 products
- American Health Packaging5 products
- Preferred Pharmaceuticals Inc.5 products
- Coupler LLC4 products
- St. Mary's Medical Park Pharmacy4 products
- Major Pharmaceuticals4 products
- Cardinal Health 107, LLC4 products
- Unit Dose Solutions, Inc.3 products
- Quality Care Products, LLC2 products
- Azurity Pharmaceuticals, Inc.1 product
- RedPharm Drug, Inc.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 |
|---|---|---|---|
| NDA019777 ZESTRIL | Twi Pharms | May 19, 1988 | 61, latest July 21, 2017 2017: Labeling · 2016: Labeling · 2015: Labeling |
| NDA208401 QBRELIS | Azurity | July 29, 2016 | 1, latest July 28, 2017 2017: Labeling |
Generic approvals (11)
- ANDA075743Prinston Inc · July 1, 2002
- ANDA075903Annora Pharma · July 1, 2002
- ANDA076059Watson Labs · July 1, 2002
- ANDA076164Prinston Inc · July 1, 2002
- ANDA076102Heritage · September 30, 2002
- ANDA077321Lupin · September 9, 2005
- ANDA077622Aurobindo · February 22, 2006
- ANDA203508Invagen Pharms · October 29, 2013
- ANDA212041Sciegen Pharms · September 15, 2020
- ANDA208920Sciegen Pharms · March 4, 2021
- ANDA076180—
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.
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November 15, 2024 · Class II · Terminated · D-0061-2025
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Pack — Evaric Pharmaceuticals Inc.
-
October 27, 2023 · Class III · Terminated · D-0114-2024
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141. — NCS Healthcare of Kentucky Inc
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September 13, 2022 · Class II · Terminated · D-1536-2022
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03 — Lupin Pharmaceuticals Inc.
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July 17, 2020 · Class II · Terminated · D-1413-2020
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08 — Lupin Pharmaceuticals Inc.
-
May 28, 2020 · Class II · Terminated · D-1290-2020
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03. — Lupin Pharmaceuticals Inc.
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April 1, 2020 · Class II · Terminated · D-1079-2020
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01 — Lupin Pharmaceuticals Inc.
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August 13, 2018 · Class II · Terminated · D-1077-2018
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03 — Lupin Pharmaceuticals Inc.
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April 6, 2016 · Class III · Terminated · D-1503-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-51 — Lupin Pharmaceuticals Inc.
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April 6, 2016 · Class III · Terminated · D-1502-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; — Lupin Pharmaceuticals Inc.
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April 9, 2013 · Class III · Terminated · D-498-2013
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India — Aurobindo Pharma USA 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) — Zestril, Upsher-Smith Laboratories, LLC, effective January 2, 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 →