Prescription medicine
Quinapril First approved as Accupril
Quinapril (Accupril) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the quinapril FDA label on DailyMed (effective December 14, 2023, Lupin Pharmaceuticals, Inc.); the NDA 19885 record on Drugs@FDA; every quinapril label on DailyMed.
Highlights of the record
FDA label of December 14, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
FETAL TOXICITY •.
When pregnancy is detected, discontinue quinapril tablets as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS : Fetal Toxicity
Used for
From the label: indications and usageHypertension Quinapril tablets USP are indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 5 mg
- 10 mg
- 20 mg
- 40 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- November 19, 1991 Accupril, Pfizer Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first December 15, 2004; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 9 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 12 of 16 presentations limited or unavailable updated October 2, 2026
- Recalls by its makers (FDA)
- 7 since 2013 0 Class I among all firms' recalls; latest December 7, 2022; 3 more by firms not listed as its makers
- FAERS reports
- 7,842 through July 30, 2026
What is quinapril used for?
From the label: indications and usageHypertension 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets USP. […]
Conditions named in the indications of quinapril's FDA labels, with every medicine labeled for each:
From other quinapril labelsHigh blood pressure: INDICATIONS AND USAGE Hypertension Quinapril tablets USP are indicated for the treatment of hypertension, to lower blood pressure.
Heart failure: Heart Failure Quinapril tablets USP is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis.
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor.
Source: FDA drug label (Quinapril), Lupin Pharmaceuticals, Inc., effective December 14, 2023 (SPL set 8ded0773-3aec-4e89-9836-d22a5a84abf0), via openFDA; the full label on DailyMed
Is there a generic for quinapril (Accupril)?
The FDA approved the first generic quinapril on December 15, 2004. 12 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists quinapril from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 2004 first generic approved
- 2023 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is quinapril in shortage?
The FDA Drug Shortage Database lists 12 of 16 quinapril presentations as limited or unavailable (updated October 2, 2026); the first entry was posted on January 19, 2023. 4 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Quinapril Hydrochloride, Tablet, 10 mg (NDC 43547-411-09) | Solco Healthcare US, LLC | Current | June 29, 2026 |
| Quinapril Hydrochloride, Tablet, 10 mg (NDC 62135-485-90) | Chartwell Molecular Holdings LLC | Current | October 2, 2026 |
| Quinapril Hydrochloride, Tablet, 10 mg (NDC 65862-618-90) | Aurobindo Pharma USA | Current | October 2, 2026 |
| Quinapril Hydrochloride, Tablet, 10 mg (NDC 65862-618-90) | Aurobindo Pharma USA | Current | October 2, 2026 |
| Quinapril Hydrochloride, Tablet, 10 mg (NDC 68180-557-09) | Lupin Pharmaceuticals, Inc. | Current | September 1, 2026 |
| Quinapril Hydrochloride, Tablet, 20 mg (NDC 43547-412-09) | Solco Healthcare US, LLC | Current | June 29, 2026 |
| Quinapril Hydrochloride, Tablet, 20 mg (NDC 62135-486-90) | Chartwell Molecular Holdings LLC | Current | October 2, 2026 |
| Quinapril Hydrochloride, Tablet, 20 mg (NDC 68180-558-09) | Lupin Pharmaceuticals, Inc. | Current | September 1, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has quinapril been recalled?
The FDA's Enforcement Report lists 10 recalls naming quinapril since 2013: 0 Class I (the most serious), 7 Class II, 3 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of quinapril and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 7, 2022 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. |
| December 7, 2015 | Class III | Lupin Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications; Impurity A |
| February 27, 2015 | Class III | AVKARE Inc. | Subpotent Drug |
| September 17, 2013 | Class II | Lupin Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; QUINAPRIL Tablet, 40 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 16714002104, Pedigree: AD52778_73, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; QUINAPRIL HCL Tablet, 10 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 80 mg, NDC 23155011401, Pedigree: AD42566_4, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: W003553, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the quinapril label say about other medicines?
The quinapril label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name quinapril. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | contraindications | Do not co-administer quinapril with aliskiren in patients with diabetes. |
| Captopril | warnings | Neutropenia/Agranulocytosis Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression rarely in patients with uncomplicated hypertension, but more frequently in patients with renal impairment, especially if they also have a collagen vascular disease, such as systemic lupus … |
| Enalapril | warnings | In controlled studies, syncope was observed in 0.4% of patients (N=3203); this incidence was similar to that observed for captopril (1%) and enalapril (0.8%). |
| Epinephrine | warnings | Where there is involvement of the tongue, glottis, or larynx likely to cause airway obstruction, emergency therapy including, but not limited to, subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL) should be promptly administered (see ADVERSE REACTIONS ). |
| Sacubitril and valsartan | contraindications | Do not administer quinapril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS ). |
| Temsirolimus | warnings | Patients taking concomitant mammalian target of rapamycin (mTOR) inhibitor (e.g., temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema. |
Source: FDA drug label (Quinapril), Lupin Pharmaceuticals, Inc., effective December 14, 2023 (SPL set 8ded0773-3aec-4e89-9836-d22a5a84abf0), via openFDA; the full label on DailyMed
What do FAERS reports show for quinapril?
The FDA Adverse Event Reporting System holds 7,842 reports that list quinapril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 613 are coded as a death and 2,827 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as quinapril?
78 other medicines are given the same way (oral) and in the same FDA class as quinapril or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lisinopril | High blood pressure, Heart failure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Enalapril | High blood pressure, Heart failure | 29 labelers | $0.0664 per tablet 10 mg tablet | No current entry |
| Hydrochlorothiazide and lisinopril | High blood pressure | 27 labelers | $0.0293 per tablet 10-12.5 mg tablet | No current entry |
| Amlodipine and benazepril | High blood pressure | 16 labelers | $0.114 per unit 10-20 mg | No current entry |
| Benazepril | High blood pressure | 21 labelers | $0.0789 per tablet 20 mg tablet | No current entry |
| Ramipril | High blood pressure | 17 labelers | $0.0707 per capsule 10 mg capsule | No current entry |
| Captopril | High blood pressure, Heart failure | 13 labelers | $0.228 per tablet 12.5 mg tablet | No current entry |
| Fosinopril | High blood pressure, Heart failure | 7 labelers | $0.154 per tablet 10 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does quinapril compare with medicines for the same use?
7 side-by-side pages set quinapril beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to quinapril
- 78 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Quinapril side effects
- the label's list beside FAERS reports
- Quinapril shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other