# FDA recall D-1063-2016

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2016-06-03.

## Product

Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01

## Reason for recall

Failed impurities/degradation: out of specification result for impurity secorapamycin.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1063-2016
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-06-03
- **Report date:** 2016-07-13
- **Termination date:** 2017-04-07

- **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-1063-2016

## Citation

> AI Analytics. FDA recall D-1063-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1063-2016. Source: US FDA. Licensed CC0.

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