# FDA recall D-0289-2015

> **Zydus Pharmaceuticals USA Inc** · Class III · drug recall initiated 2014-09-24.

## Product

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01

## Reason for recall

Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.

## Distribution

US Nationwide including Puerto Rico

## Key facts

- **Recall number:** D-0289-2015
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-09-24
- **Report date:** 2014-12-10
- **Termination date:** 2017-06-21

- **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-0289-2015

## Citation

> AI Analytics. FDA recall D-0289-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0289-2015. Source: US FDA. Licensed CC0.

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