Class IIReported 2025-12-17
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
Recalled by Cipla USA, Inc.
Reason for Recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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Recall NumberD-0225-2026ClassificationClass IIStatusOngoingCategorydrugInitiated2025-11-14Reported2025-12-17DistributionNationwide in the USCode InfoLot 5PB0164, exp 1/31/2027Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.