CLASS II ONGOING Drug recall · Reported 1 Jul 2026 · FDA Enforcement Report
Sensipar (cinacalcet) Tablets, 60mg recalled by Amgen
Amgen is recalling Sensipar (cinacalcet) Tablets, 60mg, distributed nationwide in the US. The recall was initiated on 4 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0614-2026
- FDA event ID
- 99077
- Recalling firm
- Amgen, Thousand Oaks, CA
- Brand
- Sensipar
- Manufacturer
- Amgen Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jun 2026
- FDA classified
- 23 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 4 Jun 2026 | Recall initiated by company | |
| 23 Jun 2026 | Classified by FDA | +19 days |
| 1 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: 1157055, Exp. Date 1/31/2028
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 99077This product is part of a recall event; the main page for the event is Corlanor (ivabradine) tablets, 7.5mg recalled by Amgen.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Corlanor (ivabradine) tablets, 7.5mg recalled by AmgenCorlanor | Amgen | Other | Nationwide | |
| CLASS II | Corlanor (ivabradine) tablets, 5 mg recalled by AmgenCorlanor | Amgen | Packaging Defects | Nationwide | |
| CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Amgen
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 5 mg recalled by AmgenCorlanor | Amgen | Packaging Defects | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 7.5mg recalled by AmgenCorlanor | Amgen | Other | Nationwide |
| Drug | CLASS II | Neupogen (filgrastim) For Injection, 480 mcg recalled by AmgenNeupogen | Amgen | Potency & Assay | Nationwide |
Other Cinacalcet recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |