# FDA recall D-0995-2019

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2019-02-06.

## Product

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.

## Reason for recall

Discoloration: Esomeprazole Magnesium DR Capsules (40mg)  may contain brown pellets.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0995-2019
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-06
- **Report date:** 2019-02-20
- **Termination date:** 2021-01-26

- **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-0995-2019

## Citation

> AI Analytics. FDA recall D-0995-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0995-2019. Source: US FDA. Licensed CC0.

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