Recall: D-0450-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-16Initiated

OngoingStatus

Cipla USA, Inc.Firm

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

Reason

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Distribution

Nationwide in the USA

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