# FDA recall D-0702-2017

> **Sun Pharmaceutical Industries, Inc.** · Class III · drug recall initiated 2017-03-22.

## Product

Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.

## Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0702-2017
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-22
- **Report date:** 2017-05-17
- **Termination date:** 2018-07-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0702-2017

## Citation

> AI Analytics. FDA recall D-0702-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0702-2017. Source: US FDA. Licensed CC0.

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