Cinacalcet Hydrochloride Tablets, 60 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: 69097-411-02

Recall Number: D-0450-2026

Firm: Cipla USA, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260422

Initiation Date: 20260316

Termination Date:

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

Cinacalcet Hydrochloride Tablets, 60 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: 69097-411-02