# FDA recall D-0432-2017

> **Shire PLC** · Class III · drug recall initiated 2016-12-02.

## Product

Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81

## Reason for recall

Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0432-2017
- **Recalling firm:** Shire PLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-02
- **Report date:** 2017-01-25
- **Termination date:** 2018-06-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0432-2017

## Citation

> AI Analytics. FDA recall D-0432-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0432-2017. Source: US FDA. Licensed CC0.

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