Quick answers
- What is Prazosin hydrochloride used for?
- The FDA-approved label (Prazosin Hydrochloride, Remedyrepack Inc., August 5, 2026) says: “Prazosin hydrochloride capsules 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 this drug. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Prazosin hydrochloride have a boxed warning?
- No. None of the 66 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Prazosin hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Prazosin hydrochloride been recalled?
- FDA enforcement reports list 10 recalls of products of this medicine; the newest started March 27, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Prazosin hydrochloride?
- 33 companies list prescription products of Prazosin hydrochloride in the FDA NDC Directory, including Remedyrepack Inc., Bryant Ranch Prepack and Coupler LLC.
What Prazosin hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Prazosin hydrochloride capsules 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 this drug. …
— FDA label: Prazosin Hydrochloride, Remedyrepack Inc., effective August 5, 2026. Read the full label on DailyMed →
The FDA has 66 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.
The label quoted above has no boxed warning.
0 of 66 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 111 in the FDA NDC Directory |
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 |
|---|---|---|
| prazosin hydrochloride 1 mg capsule | Generic | $0.0838 per capsule |
| prazosin hydrochloride 2 mg capsule | Generic | $0.0831 per capsule |
| prazosin hydrochloride 5 mg capsule | Generic | $0.1398 per capsule |
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.
- Remedyrepack Inc.12 products
- Bryant Ranch Prepack8 products
- Coupler LLC6 products
- Aphena Pharma Solutions - Tennessee, LLC5 products
- Exelan Pharmaceuticals3 products
- Proficient Rx LP3 products
- Marlex Pharmaceuticals, Inc.3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Aurobindo Pharma Limited3 products
- Preferred Pharmaceuticals Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- Biocon Pharma Inc.3 products
- Lifestar Pharma LLC3 products
- Novadoz Pharmaceuticals LLC3 products
- Lannett Company, Inc.3 products
- Mylan Institutional Inc.3 products
- Prasco Laboratories3 products
- Safecor Health LLC3 products
- Alembic Pharmaceuticals Inc.3 products
- Granules Pharmaceuticals Inc.3 products
- Direct_Rx3 products
- Major Pharmaceuticals3 products
- Alembic Pharmaceuticals Limited3 products
- American Health Packaging3 products
- Teva Pharmaceuticals USA, Inc.3 products
- Asclemed USA, Inc.3 products
- ANI Pharmaceuticals, Inc.3 products
- Unit Dose Solutions, Inc.2 products
- A-S Medication Solutions2 products
- St. Mary's Medical Park Pharmacy2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Cardinal Health 107, LLC2 products
- NuCare Pharmaceuticals, 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 |
|---|---|---|---|
| NDA017442 MINIPRESS | Pfizer | June 23, 1976 | 34, latest January 8, 2016 2016: Manufacturing (CMC) · 2015: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (10)
- ANDA071745Teva Pharms · September 12, 1988
- ANDA072575Mylan · February 28, 1989
- ANDA210971Novitium Pharma · October 3, 2018
- ANDA214608Granules · December 23, 2021
- ANDA213406Appco · October 21, 2022
- ANDA215697Mankind Pharma · December 30, 2022
- ANDA217268Alembic · March 6, 2023
- ANDA213052Aurobindo Pharma Ltd · March 31, 2023
- ANDA214083Lannett Co Inc · January 3, 2024
- ANDA216727Msn · September 17, 2024
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.
-
March 27, 2026 · Class II · Ongoing · D-0420-2026
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11. — Appco Pharma LLC
-
March 27, 2026 · Class II · Ongoing · D-0419-2026
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11. — Appco Pharma LLC
-
March 27, 2026 · Class II · Ongoing · D-0421-2026
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11. — Appco Pharma LLC
-
October 16, 2025 · Class II · Ongoing · D-0102-2026
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11 — Amerisource Health Services LLC
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October 16, 2025 · Class II · Ongoing · D-0101-2026
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11 — Amerisource Health Services LLC
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October 16, 2025 · Class II · Ongoing · D-0103-2026
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33 — Amerisource Health Services LLC
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October 7, 2025 · Class II · Ongoing · D-0104-2026
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10 — Teva Pharmaceuticals USA, Inc
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October 7, 2025 · Class II · Ongoing · D-0106-2026
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093- — Teva Pharmaceuticals USA, Inc
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October 7, 2025 · Class II · Ongoing · D-0105-2026
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10 — Teva Pharmaceuticals USA, Inc
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April 13, 2022 · Class II · Terminated · D-1093-2022
cGMP deviations: Temperature abuse
Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-1101-01 — Mckesson Medical-Surgical Inc. Corporate Office
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) | 198141, 312593, 312594 |
|---|---|
| SPL set ID of the quoted label | 2f86fc8e-71c1-4749-b67e-86d86cf1d984 |
| FDA labels (SPL) | 66 |
| FDA applications | NDA017442, 10 ANDA |
| Active ingredients (FDA) | PRAZOSIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prazosin Hydrochloride, Remedyrepack Inc., effective August 5, 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 →