Amgen, Inc.: Sensipar (cinacalcet) Tablets, 60mg, 30-count Bottles
Sensipar Recall Summary Amgen is recalling 60mg bottles of Sensipar (cinacalcet) tablets nationwide due to manufacturing process deviations that don't meet current Good Manufacturing Practice standards. The affected product was distributed across all U.S. states and was made in Japan. This is a Class II recall, meaning the product could cause adverse health effects but is unlikely to result in serious injury.
- Recalling firm
- Amgen, Inc.
- Product
- Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
- 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/aeea1053-afe6-428d-924c-f34da68656ac