# FDA recall D-0086-2024

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2023-10-13.

## Product

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

## Reason for recall

Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0086-2024
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-10-13
- **Report date:** 2023-11-15
- **Termination date:** 2024-09-09

- **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-0086-2024

## Citation

> AI Analytics. FDA recall D-0086-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0086-2024. Source: US FDA. Licensed CC0.

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