# FDA recall D-1315-2020

> **Aurobindo Pharma USA Inc.** · Class III · drug recall initiated 2020-05-26.

## Product

Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30

## Reason for recall

Failed Impurities/ Degradation Specifications

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1315-2020
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-05-26
- **Report date:** 2020-06-24
- **Termination date:** 2023-01-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1315-2020

## Citation

> AI Analytics. FDA recall D-1315-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-1315-2020. Source: US FDA. Licensed CC0.

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