# FDA recall D-014-2014

> **Pfizer Us Pharmaceutical Group** · Class II · drug recall initiated 2013-09-04.

## 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.

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-014-2014
- **Recalling firm:** Pfizer Us Pharmaceutical Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-04
- **Report date:** 2013-11-27
- **Termination date:** 2017-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-014-2014

## Citation

> AI Analytics. FDA recall D-014-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-014-2014. Source: US FDA. Licensed CC0.

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