# FDA recall D-0389-2019

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2019-01-15.

## Product

Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count  bottles, Rx only, Manufactured by: Teva  Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10

## Reason for recall

Presence of Foreign Substance: Product complaint of black speckles observed on tablets.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0389-2019
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-15
- **Report date:** 2019-01-30
- **Termination date:** 2020-03-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2019

## Citation

> AI Analytics. FDA recall D-0389-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0389-2019. Source: US FDA. Licensed CC0.

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