Why it was recalled
CGMP Deviations
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
Lot numbers, UPCs & expiration codes
Lot #: 1157056, Exp. Date 02/29/2028
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0616-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 4, 2026
- FDA report date
- Jul 1, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amgen, Inc.
Original FDA data
Every field from FDA enforcement report D-0616-2026, exactly as published.
Show all FDA fields
- City
- Thousand Oaks
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 99077
- Address
- 1 Amgen Center Dr
- Code information
- Lot #: 1157056, Exp. Date 02/29/2028
- Postal code
- 91320-1730
- Report date
- Jul 1, 2026
- Product type
- Drugs
- Recall number
- D-0616-2026
- Classification
- Class II
- Recalling firm
- Amgen, Inc.
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 4, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2026