# FDA recall D-0325-2015

> **Zydus Pharmaceuticals USA Inc** · Class II · drug recall initiated 2014-12-23.

## Product

Benzonatate Capsules, USP, 100 mg,  Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534;  100-bottle capsules  - NDC 68382-247-01  500-bottle capsules - NDC 68382-247-05

## Reason for recall

Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0325-2015
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-23
- **Report date:** 2014-12-31
- **Termination date:** 2017-09-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0325-2015

## Citation

> AI Analytics. FDA recall D-0325-2015. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0325-2015. Source: US FDA. Licensed CC0.

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