FDA recall D-0616-2026

Product

Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30

Reason for recall

CGMP Deviations

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2026-06-04

Report date

2026-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0616-2026