# FDA recall D-0053-2018

> **Aidarex Pharmaceuticals LLC** · Class III · drug recall initiated 2017-09-05.

## Product

ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.

## Reason for recall

Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.

## Distribution

Product was distributed in Florida

## Key facts

- **Recall number:** D-0053-2018
- **Recalling firm:** Aidarex Pharmaceuticals LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-05
- **Report date:** 2017-11-01
- **Termination date:** 2017-12-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Corona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0053-2018

## Citation

> AI Analytics. FDA recall D-0053-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0053-2018. Source: US FDA. Licensed CC0.

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