FDA-Drug2026-07-01Class IIPROCESSING DEFECT
Amgen Sensipar (cinacalcet) 30mg tablets recalled for manufacturing quality deviations
What this means
Amgen is recalling Sensipar (cinacalcet) 30mg tablets due to deviations from manufacturing quality standards (CGMP). The recall affects one specific lot distributed nationwide. No injuries have been reported.
- If you take Sensipar, check your bottle for lot number 1156858 with expiration date 12/31/2027.
- Contact your pharmacist or doctor before stopping this medication — do not stop taking it without medical guidance.
- Your pharmacist can determine if your supply is affected and arrange a replacement if needed.
The agency's original wording
Hazard
CGMP Deviations
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
9565 bottles
Manufactured in
1 Amgen Center Dr, N/A, Thousand Oaks, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0613-2026Want us to check the next one for you?
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