Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aldactone (spironolactone) tablets Recalled by Pfizer Us Pharmaceutical Group Due to Marketed without an Approved NDA/ANDA: This recall is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pfizer Us Pharmaceutical Group directly.
Affected Products
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
Quantity: 31 bottles
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pfizer Us Pharmaceutical Group
Pfizer Us Pharmaceutical Group has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report