Class II Recall

Dr. Reddy's Laboratories, Inc.

Product
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Reason
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Classification
Class II
Status
Ongoing
Lot
Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Dr. Reddy's Laboratories, Inc. — Class II Recall | MedicineWatch US