# FDA recall D-0725-2016

> **Zydus Pharmaceuticals USA Inc** · Class III · drug recall initiated 2016-01-14.

## Product

risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India.  Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ  08534. NDC: 68382-156-06.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

## Distribution

US Nationwide including Puerto Rico

## Key facts

- **Recall number:** D-0725-2016
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-14
- **Report date:** 2016-03-02
- **Termination date:** 2020-12-18

- **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-0725-2016

## Citation

> AI Analytics. FDA recall D-0725-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0725-2016. Source: US FDA. Licensed CC0.

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