Quick answers
- What is Spironolactone used for?
- The FDA-approved label (Aldactone, Pfizer Laboratories Div Pfizer Inc, November 28, 2025) says: “ALDACTONE is an aldosterone antagonist indicated for: • The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. • Use as an add-on therapy for the treatment of hypertension, 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 Spironolactone have a boxed warning?
- The label we quote has no boxed warning, but 7 of 122 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Spironolactone?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated December 10, 2025). Ask your pharmacist about alternatives.
- Has Spironolactone been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started August 5, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Spironolactone?
- 39 companies list prescription products of Spironolactone in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and A-S Medication Solutions.
What Spironolactone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ALDACTONE is an aldosterone antagonist indicated for: • The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. • Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. …
— FDA label: Aldactone, Pfizer Laboratories Div Pfizer Inc, effective November 28, 2025. Read the full label on DailyMed →
The FDA has 122 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.
7 of 122 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, coated · Suspension |
|---|---|
| Route | Oral |
| Prescription products | 180 in the FDA NDC Directory |
| Brand names | Aldactone |
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 |
|---|---|---|
| spironolactone 100 mg tablet | Generic | $0.1640 per tablet |
| spironolactone 100 mg tablet, coated | Generic | $0.1640 per tablet |
| spironolactone 100 mg tablet, film coated | Generic | $0.1640 per tablet |
| spironolactone 25 mg tablet | Generic | $0.0426 per tablet |
| spironolactone 25 mg tablet, coated | Generic | $0.0426 per tablet |
| spironolactone 25 mg tablet, film coated | Generic | $0.0426 per tablet |
| spironolactone 25 mg/5 mL suspension | Generic | $1.81–$1.89 per mL 6 packages, lowest to highest |
| spironolactone 25 mg/5 mL suspension | Brand: CaroSpir | $3.45 per mL |
| spironolactone 50 mg tablet | Generic | $0.0833 per tablet |
| spironolactone 50 mg tablet, coated | Generic | $0.0833 per tablet |
| spironolactone 50 mg tablet, film coated | Generic | $0.0833 per tablet |
NADAC list of November 4, 2026; these prices took effect between September 23, 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.
- Bryant Ranch Prepack35 products
- Proficient Rx LP13 products
- A-S Medication Solutions13 products
- Remedyrepack Inc.9 products
- Asclemed USA, Inc.8 products
- NuCare Pharmaceuticals, Inc.8 products
- Aphena Pharma Solutions - Tennessee, LLC7 products
- PD-Rx Pharmaceuticals, Inc.6 products
- Jubilant Cadista Pharmacuticals Inc.6 products
- Northwind Health Company, LLC4 products
- Preferred Pharmaceuticals Inc.4 products
- Camber Pharmaceuticals, Inc.4 products
- Rising Pharma Holdings, Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- Zydus Lifesciences Limited3 products
- Direct_Rx3 products
- Safecor Health LLC3 products
- Pfizer Laboratories Div Pfizer Inc3 products
- Amneal Pharmaceuticals LLC3 products
- Zydus Pharmaceuticals USA Inc.3 products
- NorthStar Rx LLC3 products
- Mylan Institutional Inc.3 products
- Coupler LLC3 products
- Oxford Pharmaceuticals, LLC3 products
- Aurobindo Pharma Limited3 products
- Accord Healthcare Inc.3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Amneal Pharmaceuticals of New York LLC3 products
- American Health Packaging3 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Atlantic Biologicals Corp.2 products
- Cardinal Health 107, LLC2 products
- Redpharm Drug2 products
- QPharma, Inc.2 products
- Padagis US LLC1 product
- Major Pharmaceuticals1 product
- PharmPak, Inc.1 product
- CMP Pharma, Inc.1 product
- Amneal Pharmaceuticals NY LLC1 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 |
|---|---|---|---|
| NDA012151 ALDACTONE | Pfizer | January 21, 1960 | 41, latest November 14, 2025 2025: Labeling · 2022: Labeling · 2020: Labeling |
| NDA209478 CAROSPIR | Cmp Dev LLC | August 4, 2017 | 3, latest August 24, 2023 2023: Labeling · 2021: Manufacturing (CMC) · 2021: Labeling |
Generic approvals (12)
- ANDA089424Sun Pharm Industries · July 23, 1986
- ANDA040424Mylan · August 20, 2001
- ANDA040750Oxford Pharms · August 29, 2006
- ANDA091426Amneal Pharms · July 2, 2010
- ANDA202187Aurobindo Pharma · March 6, 2014
- ANDA203253Jubilant Generics · April 23, 2014
- ANDA203512Accord Hlthcare · September 19, 2016
- ANDA205936Zydus Pharms · July 18, 2018
- ANDA215572Amneal · September 5, 2023
- ANDA219494Graviti Pharms · January 23, 2025
- ANDA218085Hetero Labs Ltd III · February 21, 2025
- ANDA217761Annora Pharma · July 25, 2025
Shortage status
To be discontinued · updated December 10, 2025 · first posted December 10, 2025
| Product | Aldactone, Tablet, 25 mg (NDC 0025-1001-31) |
|---|---|
| Company | Pfizer 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.
-
August 5, 2025 · Class II · Ongoing · D-0574-2025
Presence of foreign substance: identified as aluminum.
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143- — SUN PHARMACEUTICAL INDUSTRIES INC
-
September 4, 2013 · Class II · Terminated · D-014-2014
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31 — Pfizer Us Pharmaceutical Group
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) — Aldactone, Pfizer Laboratories Div Pfizer Inc, effective November 28, 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 →