FDA Drug recall D-0613-2026
Sensipar (cinacalcet) Tablets, 30mg, 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, 30mg, 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-0613-2026 |
| 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, 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
Reason
CGMP Deviations
Identifiers
| ndc | 55513-073-30 |
|---|---|
| ndc | 55513-074-30 |
| ndc | 55513-075-30 |
| code_info | Lot#: 1156858, Exp. Date 12/31/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Amgen
- Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799,…
FDA Drug · Class II · 2026-07-01 · Amgen - 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 · 2026-07-01 · Amgen - Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy
FDA Drug · Class II · 2026-07-01 · Amgen - Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx…
FDA Drug · Class II · 2026-07-01 · Amgen - Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Soluti…
FDA Drug · Class II · 2025-03-26 · Amgen
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0613-2026%22
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