Amgen, Inc.: Sensipar (cinacalcet) Tablets, 30mg, 30-count Bottles

Sensipar Recall Summary Amgen is recalling 30mg bottles of Sensipar (cinacalcet) tablets nationwide due to manufacturing process deviations that don't meet quality standards. The affected product was distributed across all U.S. states and the District of Columbia. This is a Class II recall, meaning the product could cause adverse health effects.

Recalling firm
Amgen, Inc.
Product
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
Reason
CGMP Deviations
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-06-04
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide within the United States

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/fa83f7c2-6506-4b61-be96-07997ca499d8