# FDA recall D-0101-2018

> **Zydus Pharmaceuticals USA Inc** · Class II · drug recall initiated 2017-11-20.

## Product

Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06),   b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534

## Reason for recall

Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0101-2018
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-11-20
- **Report date:** 2017-12-06
- **Termination date:** 2020-09-01

- **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-0101-2018

## Citation

> AI Analytics. FDA recall D-0101-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0101-2018. Source: US FDA. Licensed CC0.

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