← FDA ENFORCEMENT
D-0613-2026Class II

Amgen, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Amgen, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-07-01
Distribution
Nationwide within the United States
Firm state
CA
Product quantity
9565 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

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

Code / lot info

Lot#: 1156858, Exp. Date 12/31/2027.

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →