# FDA recall D-0991-2018

> **Aidarex Pharmaceuticals LLC** · Class III · drug recall initiated 2018-06-27.

## Product

Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India.  NDC: 33261-0693-90

## Reason for recall

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0991-2018
- **Recalling firm:** Aidarex Pharmaceuticals LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-27
- **Report date:** 2018-08-01
- **Termination date:** 2019-12-04

- **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-0991-2018

## Citation

> AI Analytics. FDA recall D-0991-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0991-2018. Source: US FDA. Licensed CC0.

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