FDA Drug recall D-0614-2026
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799,…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799,… by Amgen, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0614-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-04 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amgen |
| Distribution | US |
Product
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
Reason
CGMP Deviations
Identifiers
| ndc | 55513-073-30 |
|---|---|
| ndc | 55513-074-30 |
| ndc | 55513-075-30 |
| code_info | Lot #: 1157055, Exp. Date 1/31/2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0614-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.