Cinacalcet Hydrochloride Tablets, 90 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 69097-412-02

Recall Number: D-0676-2026

Firm: Cipla USA, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260708

Initiation Date: 20260629

Termination Date:

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

Cinacalcet Hydrochloride Tablets, 90 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 69097-412-02