Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Recalled December 17, 2025 · FDA recall D-0224-2026 · Cipla USA
Hazard
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. · FDA Class II
Units
63,504 bottles
Sold at
Nationwide in the US
Description
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Manufacturer(s)
Cipla USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →