# FDA recall D-0026-2025

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2024-10-09.

## Product

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

## Reason for recall

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

## Distribution

USA Nationwide.

## Key facts

- **Recall number:** D-0026-2025
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-10-09
- **Report date:** 2024-11-06

- **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-0026-2025

## Citation

> AI Analytics. FDA recall D-0026-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-0026-2025. Source: US FDA. Licensed CC0.

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