# FDA recall D-1038-2016

> **Par Pharmaceutical** · Class III · drug recall initiated 2016-05-28.

## Product

Pramipexole Dihydrochloride Extended Release  Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11

## Reason for recall

Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-1038-2016
- **Recalling firm:** Par Pharmaceutical
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-05-28
- **Report date:** 2016-06-22
- **Termination date:** 2017-03-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chestnut Ridge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1038-2016

## Citation

> AI Analytics. FDA recall D-1038-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1038-2016. Source: US FDA. Licensed CC0.

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