# FDA recall D-0077-2025

> **Aurobindo Pharma USA Inc** · Class II · drug recall initiated 2024-11-07.

## Product

Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

## Reason for recall

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

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0077-2025
- **Recalling firm:** Aurobindo Pharma USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-07
- **Report date:** 2024-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0077-2025

## Citation

> AI Analytics. FDA recall D-0077-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0077-2025. Source: US FDA. Licensed CC0.

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