Amgen recalls
Amgen appears in 12 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-01.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 12 |
|---|---|
| Published | 2013-11-13 to 2026-07-01 |
| By agency | FDA Drug (12) |
| By classification | Class II (12) |
| By status | ongoing (7), terminated (5) |
| Distribution named in notices | PR, US |
Recalls
- 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
Reason: CGMP Deviations - 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
Reason: CGMP Deviations - 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
Reason: Presence of Foreign Substance. - 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 · 2026-07-01 · Amgen
Reason: CGMP Deviations - 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
Reason: Presence of Foreign Substance. - 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
Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. - Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use O…
FDA Drug · Class II · 2025-03-26 · Amgen
Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. - MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen…
FDA Drug · Class II · 2022-05-18 · Amgen
Reason: Defective container: loose crimp defect, potential loss of container integrity. - Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL via…
FDA Drug · Class II · 2017-09-27 · Amgen
Reason: Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection. - Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thous…
FDA Drug · Class II · 2017-08-23 · Amgen
Reason: Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials. - AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactu…
FDA Drug · Class II · 2016-12-28 · Amgen
Reason: Lack of Assurance of Sterility: Potential cracks in glass vials - Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Lt…
FDA Drug · Class II · 2013-11-13 · Amgen
Reason: Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.