Sensipar Tablet, Coated
FDA Recall NDC 55513-073
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Sensipar (NDC 55513-073). A significant event, classified as Class II, was initiated on Jun 04, 2026 by Amgen Inc. The reported reason for this action was: "CGMP Deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations
Jun 04, 2026
Jul 01, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99077
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amgen, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# : 1157055, Exp. Date 1/31/2028
Affected Packages Involved in this Recall
55513-073-30Product
55513-074-30Product
55513-075-30Product
Class II Ongoing
CGMP Deviations
Jun 04, 2026
Jul 01, 2026
9565 bottles
Recall Profile & Regulatory Data
Event ID
99077
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amgen, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : 1156858, Exp. Date 12/31/2027.
Affected Packages Involved in this Recall
55513-073-30Product
55513-074-30Product
55513-075-30Product
Class II Ongoing
CGMP Deviations
Jun 04, 2026
Jul 01, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99077
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amgen, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# : 1157056, Exp. Date 02/29/2028
Affected Packages Involved in this Recall
55513-073-30Product
55513-074-30Product
55513-075-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
