FDA recall D-0226-2026

Cipla USA, Inc. · Class II · drug

Product

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02

Reason for recall

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Distribution

Nationwide in the US

Key facts

Status: Ongoing
Initiation date: 2025-11-14
Report date: 2025-12-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0226-2026