# FDA recall D-0451-2026

> **Cipla USA, Inc.** · Class II · drug recall initiated 2026-03-16.

## Product

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

## Reason for recall

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0451-2026
- **Recalling firm:** Cipla USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-16
- **Report date:** 2026-04-22

- **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-0451-2026

## Citation

> AI Analytics. FDA recall D-0451-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0451-2026. Source: US FDA. Licensed CC0.

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