Product: 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
Reason for recall: 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.
Recall initiated: 20130904
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated