Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla ...
FDA Recall #D-0225-2026 — Class II — November 14, 2025
Product Description
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
Reason for Recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recalling Firm
Cipla USA, Inc. — Warren, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
15,744 bottles
Distribution
Nationwide in the US
Code Information
Lot 5PB0164, exp 1/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated