FDA-Drug2026-07-01Class IIPROCESSING DEFECT

Amgen Sensipar 60mg tablets recalled for manufacturing quality deviations

OTHERNationwide distributionDrugs

What this means

Amgen is recalling Sensipar (cinacalcet) 60mg tablets due to deviations from manufacturing standards. The recall affects one lot (1157055) with an expiration date of January 31, 2028, distributed nationwide.

  • Check if you have Sensipar lot #1157055 (expiration 1/31/2028).
  • Do not stop taking your medication without consulting your doctor.
  • Contact your pharmacy or Amgen for instructions on replacement or verification.
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The agency's original wording
Hazard

CGMP Deviations

Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
N/A
Manufactured in
1 Amgen Center Dr, N/A, Thousand Oaks, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0614-2026

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