# FDA recall D-0661-2026

> **Cipla USA, Inc.** · Class II · drug recall initiated 2026-06-29.

## Product

Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02

## Reason for recall

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0661-2026
- **Recalling firm:** Cipla USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-06-29
- **Report date:** 2026-07-08

- **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-0661-2026

## Citation

> MORVS. FDA recall D-0661-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/D-0661-2026. Source: US FDA. Licensed CC0.

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