FDA-Drug2026-07-01Class IIPROCESSING DEFECT

Amgen Sensipar (cinacalcet) 90mg tablets recalled for manufacturing compliance issues

OTHERNationwide distribution

Amgen Sensipar cinacalcet tablets recalled for manufacturing deviations

Amgen is recalling Sensipar (cinacalcet) 90mg tablets due to deviations from current good manufacturing practice (CGMP) standards. This affects one lot distributed nationwide. No injuries have been reported.

  • Check if your Sensipar matches lot #1157056 (expiration 02/29/2028).
  • Contact your pharmacy or doctor before stopping this medication.
  • Return the affected medication to your pharmacy or follow your doctor's instructions.
Hazard

CGMP Deviations

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, 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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0616-2026

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