# FDA recall D-0085-2022

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2021-10-05.

## Product

Dr. Reddy's  Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05

## Reason for recall

Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0085-2022
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-05
- **Report date:** 2021-11-10
- **Termination date:** 2023-02-16

- **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-0085-2022

## Citation

> AI Analytics. FDA recall D-0085-2022. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0085-2022. Source: US FDA. Licensed CC0.

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