# FDA recall D-0226-2026

> **Cipla USA, Inc.** · Class II · drug recall initiated 2025-11-14.

## Product

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.  NDC: 69097-412-02

## Reason for recall

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0226-2026
- **Recalling firm:** Cipla USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-11-14
- **Report date:** 2025-12-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0226-2026

## Citation

> AI Analytics. FDA recall D-0226-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0226-2026. Source: US FDA. Licensed CC0.

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