Amgen, Inc.
Amgen, Inc. appears in FDA public data with 12 recalls, 2 510(k) clearances, 28 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0616-2026, Class II) was initiated on Jun 4, 2026. Its most recent 510(k) clearance was granted on Oct 10, 1989.
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 2
- Inspections
- 28
- Compliance Actions
- 1
Known Names
Amgen, Amgen-Manufacturing-Limited, Amgen-Singapore-Manufacturing-Pte, Amgen-Technology-Ireland-Unlimited, Amgen Singapore Manufacturing Pte, Amgen Technology Ireland Unlimited, Amgen Manufacturing Limited, Amgen Europe, Amgen-Europe, Amgen Singapore Manufacturing
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0616-2026 | Class II | Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Cent | Jun 4, 2026 |
| D-0613-2026 | Class II | Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Cent | Jun 4, 2026 |
| D-0612-2026 | Class II | Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 | Jun 4, 2026 |
| D-0615-2026 | Class II | Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 | Jun 4, 2026 |
| D-0614-2026 | Class II | Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Cent | Jun 4, 2026 |
| D-0286-2025 | Class II | Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only | Feb 27, 2025 |
| D-0285-2025 | Class II | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous | Feb 27, 2025 |
| D-0855-2022 | Class II | MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single do | May 2, 2022 |
| D-1173-2017 | Class II | Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-31 | Sep 13, 2017 |
| D-1086-2017 | Class II | Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx o | Aug 4, 2017 |
| D-0226-2017 | Class II | AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous | Dec 15, 2016 |
| D-66318-001 | Class II | Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, | Sep 17, 2013 |