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Amgen, Inc. FDA Recalls
8 recalls on file across drugs, 0 of them Class I and 7 still open. Matched by name to AMGN.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand OClass IIJun 4, 2026CGMP Deviations |
| Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDCClass IIJun 4, 2026Presence of Foreign Substance. |
| Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC Class IIJun 4, 2026Presence of Foreign Substance. |
| Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand OClass IIJun 4, 2026CGMP Deviations |
| Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand OClass IIJun 4, 2026CGMP Deviations |
| Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous oClass IIFeb 27, 2025Stability data does not support expiry: the products have th |
| Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use OClass IIFeb 27, 2025Stability data does not support expiry: the products have th |
| MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, MaClass IIMay 2, 2022Defective container: loose crimp defect, potential loss of c |