Class II

Drug Recall: Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

Cipla USA, Inc. · November 14, 2025

Reason for Recall

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Distribution

Nationwide in the US

States Affected

NATIONWIDE

Quantity Affected

15,744 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0225-2026

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.