# FDA recall D-0424-2017

> **Pfizer Inc.** · Class III · drug recall initiated 2016-09-09.

## Product

Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34

## Reason for recall

Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0424-2017
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-09-09
- **Report date:** 2017-01-18
- **Termination date:** 2017-08-18

- **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-0424-2017

## Citation

> AI Analytics. FDA recall D-0424-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0424-2017. Source: US FDA. Licensed CC0.

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