FDA recall D-0451-2026

Product

Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-03-16

Report date

2026-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2026