Quick answers
- What is Quinapril used for?
- The FDA-approved label (Quinapril, Northwind Health Company, LLC, January 1, 2026) says: “Hypertension Quinapril tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Quinapril have a boxed warning?
- Yes. The FDA label for Quinapril has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Quinapril?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 13, 2026). Ask your pharmacist about alternatives.
- Has Quinapril been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started December 7, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Quinapril?
- 9 companies list prescription products of Quinapril in the FDA NDC Directory, including Proficient Rx LP, Solco Healthcare US, LLC and Aurobindo Pharma Limited.
What Quinapril is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Hypertension Quinapril tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …
— FDA label: Quinapril, Northwind Health Company, LLC, effective January 1, 2026. Read the full label on DailyMed →
The FDA has 15 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. Read it on the full label →
11 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 33 in the FDA NDC Directory |
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.
- Proficient Rx LP4 products
- Solco Healthcare US, LLC4 products
- Aurobindo Pharma Limited4 products
- Cipla USA Inc.4 products
- Lupin Pharmaceuticals, Inc.4 products
- Chartwell RX, LLC4 products
- Bryant Ranch Prepack4 products
- BluePoint Laboratories4 products
- Northwind Health Company, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA076803Chartwell Rx · March 2, 2005
- ANDA077690Lupin · June 20, 2006
- ANDA078457Invagen Pharms · August 24, 2007
- ANDA202725Aurobindo Pharma Ltd · April 29, 2013
- ANDA205823Prinston Inc · September 15, 2016
Shortage status
Current shortage · updated October 13, 2026 · first posted January 19, 2023
| Product | Quinapril Hydrochloride, Tablet, 10 mg (NDC 68180-557-09) |
|---|---|
| Availability | Unavailable |
| Reason given | Requirements related to complying with good manufacturing practices |
| Company | Lupin Pharmaceuticals, 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.
-
December 7, 2022 · Class II · Terminated · D-0089-2023
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09 — Lupin Pharmaceuticals Inc.
-
December 7, 2022 · Class II · Terminated · D-0088-2023
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09 — Lupin Pharmaceuticals Inc.
-
December 7, 2015 · Class III · Terminated · D-0650-2017
Failed Impurities/Degradation Specifications; Impurity A
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09 — Lupin Pharmaceuticals Inc.
-
September 17, 2013 · Class II · Terminated · D-409-2014
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-557-09 — Lupin Pharmaceuticals Inc.
-
September 17, 2013 · Class II · Terminated · D-408-2014
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09 — Lupin 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) | 312748, 312749, 312750, 314203 |
|---|---|
| SPL set ID of the quoted label | da562e3b-4411-e750-e053-2a95a90ad7e5 |
| FDA labels (SPL) | 15 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | QUINAPRIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Quinapril, Northwind Health Company, LLC, effective January 1, 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 →