# FDA recall D-0051-2018

> **Wockhardt Usa Inc.** · Class III · drug recall initiated 2017-08-22.

## Product

Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;

## Reason for recall

Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0051-2018
- **Recalling firm:** Wockhardt Usa Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-22
- **Report date:** 2017-11-01
- **Termination date:** 2019-02-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0051-2018

## Citation

> AI Analytics. FDA recall D-0051-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0051-2018. Source: US FDA. Licensed CC0.

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