# FDA recall D-0242-2018

> **Boehringer Ingelheim Pharmaceuticals, Inc.** · Class II · drug recall initiated 2017-12-14.

## Product

SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule  (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47

## Reason for recall

Failed Stability Specifications

## Distribution

Distributed nationwide

## Key facts

- **Recall number:** D-0242-2018
- **Recalling firm:** Boehringer Ingelheim Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-14
- **Report date:** 2018-02-07
- **Termination date:** 2018-10-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ridgefield, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0242-2018

## Citation

> AI Analytics. FDA recall D-0242-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0242-2018. Source: US FDA. Licensed CC0.

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