# FDA recall D-0287-2021

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2021-02-17.

## Product

Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Made in India.

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0287-2021
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-17
- **Report date:** 2021-03-03
- **Termination date:** 2022-12-21

- **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-0287-2021

## Citation

> AI Analytics. FDA recall D-0287-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0287-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*