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FDAClass II · Drug · Recalled July 1, 2026
Sensipar (cinacalcet) Tablets recall — Amgen, Inc.
Hazard: CGMP Deviations
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0613-2026
- Brand
- Amgen
- Classification
- Class II
- Units affected
- 9565 bottles
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
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
Affected products
Companies & origin
- Recalling firm location
- Thousand Oaks, CA, United States
- Firm address
- 1 Amgen Center Dr, N/A, 91320-1730
Identifying details (verbatim from the notice)
- Product codes / lots
- Lot#: 1156858, Exp. Date 12/31/2027.
- Distribution
- Nationwide within the United States
- Firm notified the public via
- Letter
- FDA event ID
- 99077
- Recall initiated
- June 4, 2026
- FDA classified
- June 23, 2026
- FDA report date
- July 1, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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