Official recall notice

FDA DrugClass IINotable

FDA Recall: Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC

Recall date
2026-07-08
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Product description

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Affected products

Lot #: 5PB0563, Exp 4/30/2027

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