Class II

Drug Recall: Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

Dr. Reddy's Laboratories, Inc. · October 9, 2024

Reason for Recall

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Distribution

USA Nationwide.

States Affected

NATIONWIDE

Quantity Affected

35880 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0027-2025

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.