Aldactone — Class II drug recall D-014-2014
Terminated recall by Pfizer Us Pharmaceutical Group, reported 2013-11-27, distributed nationwide. Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution pr
| Recall number | D-014-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Us Pharmaceutical Group, New York, NY, United States |
| Recall initiated | 2013-09-04 |
| Classified | 2013-11-20 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2017-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 31 bottles |
| Reason classes | specification failure, unapproved product |
| NDC | 00025-1001, 00025-1001-31, 00025-1031, 00025-1031-31, 00025-1041, 00025-1041-31 |
| Lot numbers | 05/17, V121573 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-014-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.