Class II

Drug Recall: Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren

Cipla USA, Inc. · June 29, 2026

Reason for Recall

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

Product Description

Cinacalcet Hydrochloride Tablets, 60 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 69097-411-02

Distribution

USA Nationwide

States Affected

NATIONWIDE

Quantity Affected

N/A

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0675-2026

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.