# FDA recall D-0991-2019

> **Boehringer Ingelheim Pharmaceuticals, Inc.** · Class III · drug recall initiated 2019-03-07.

## Product

Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT  06877 USA, Made in Germany, NDC 0597-0190-61.

## Reason for recall

Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0991-2019
- **Recalling firm:** Boehringer Ingelheim Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-07
- **Report date:** 2019-03-20
- **Termination date:** 2019-09-11

- **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-0991-2019

## Citation

> AI Analytics. FDA recall D-0991-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0991-2019. Source: US FDA. Licensed CC0.

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