# FDA recall D-0504-2024

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2024-05-01.

## Product

Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0504-2024
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-05-01
- **Report date:** 2024-05-29

- **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-0504-2024

## Citation

> AI Analytics. FDA recall D-0504-2024. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0504-2024. Source: US FDA. Licensed CC0.

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