# FDA recall D-0053-2021

> **Boehringer Ingelheim Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-10-05.

## Product

Catapres (clonidine hydrochloride, USP)  0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01

## Reason for recall

An extraneous peak was observed for dissolution testing.

## Distribution

Distributed Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0053-2021
- **Recalling firm:** Boehringer Ingelheim Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-05
- **Report date:** 2020-11-04
- **Termination date:** 2021-09-29

- **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-0053-2021

## Citation

> AI Analytics. FDA recall D-0053-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0053-2021. Source: US FDA. Licensed CC0.

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