Quick answers
- What is Aldactone?
- Aldactone is a brand name of Spironolactone, a prescription medicine. The FDA NDC Directory lists 3 Aldactone products in 3 strengths and forms.
- Who makes Aldactone?
- Pfizer holds the FDA application for Aldactone (NDA012151, approved January 21, 1960).
- Is there a generic or store brand of Aldactone?
- Yes. The FDA NDC Directory lists 83 other products with the same active ingredients, strength and form as a Aldactone product, 83 of them generic. Ask your pharmacist whether one is right for you.
- Has Aldactone been recalled?
- FDA enforcement reports list 1 recall of Aldactone products; the newest started September 4, 2013. A recall usually concerns specific lots, not every product.
What Aldactone is
Each Aldactone product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Spironolactone · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| spironolactone 100 mg tablet, film coated (oral) | Aldactone | 26 products, 19 companies | DailyMed |
| spironolactone 25 mg tablet, film coated (oral) | Aldactone | 26 products, 21 companies | DailyMed |
| spironolactone 50 mg tablet, film coated (oral) | Aldactone | 31 products, 19 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Spironolactone →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA012151 | Pfizer | January 21, 1960 | 3 |
Companies that list Aldactone
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Aldactone products.
- Pfizer Laboratories Div Pfizer Inc3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.