Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;
Recalled July 8, 2026 · FDA recall D-0661-2026 · Cipla USA
Hazard
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). · FDA Class II
Units
31,824 bottles
Sold at
USA Nationwide
Description
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Product
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02
Manufacturer(s)
Cipla USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →