Recall: D-0675-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-29Initiated

OngoingStatus

Cipla USA, Inc.Firm

Product

Cinacalcet Hydrochloride Tablets, 60 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 69097-411-02

Reason

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.