Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,
Recalled April 22, 2026 · FDA recall D-0450-2026 · Cipla USA
Hazard
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit · FDA Class II
Units
96,096 bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per 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
Manufacturer(s)
Cipla USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →