Class II

Drug Recall: Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,

Cipla USA, Inc. · March 16, 2026

Reason for Recall

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

Product Description

Cinacalcet Hydrochloride Tablets, 30 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: 69097-410-02

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

113,336 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0449-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.