Amgen recalls
FDA enforcement reports naming Amgen, Inc. as the recalling firm.
- Recall reports
- 11
- Class I (serious)
- 0
- Most recent report
- Jul 1, 2026
- Jul 1, 2026Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, O…Drug · Amgen, Inc.CGMP DeviationsClass II
- Jul 1, 2026Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-9…Drug · Amgen, Inc.Presence of Foreign Substance.Class II
- Jul 1, 2026Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, O…Drug · Amgen, Inc.CGMP DeviationsClass II
- Jul 1, 2026Corlanor (ivabradine) tablets, 7Drug · Amgen, Inc.Presence of Foreign Substance.Class II
- Jul 1, 2026Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, O…Drug · Amgen, Inc.CGMP DeviationsClass II
- Mar 26, 2025Neupogen (filgrastim) For Injection, 480 mcg/1Drug · Amgen, Inc.Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.Class II
- Mar 26, 2025Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For…Drug · Amgen, Inc.Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.Class II
- May 18, 2022MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4…Drug · Amgen, Inc.Defective container: loose crimp defect, potential loss of container integrity.Class II
- Sep 27, 2017Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials…Drug · Amgen, Inc.Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.Class II
- Aug 23, 2017Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous U…Drug · Amgen, Inc.Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.Class II
- AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, Fo…
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