Amgen, Inc

Pharmaceutical company10 products tracked

products tracked

396,856

total reports

recalls on record

64.9%

serious overall

Products

showing 10 of 10

Product	Approved	Reports ↓	Top signal	Recalls
apremilast —	2014	144,030	Psoriatic arthropathy	0
bevacizumab —	2004	126,289	Proteinuria	27
darbepoetin alfa —	2001	53,035	Aplasia pure red cell	0
panitumumab —	2006	14,905	Colorectal cancer metastatic	1
romiplostim —	2008	14,658	Platelet count abnormal	1
epoetin alfa —	1989	13,801	Nephrogenic systemic fibrosis	3
romosozumab-aqqg —	2019	12,630	Bone density abnormal	1
blinatumomab —	2014	10,115	Leukaemic infiltration extramedullary	0
bevacizumab-awwb —	2017	4,526	Intercepted product administration error	2
etelcalcetide —	2017	2,867	Shunt stenosis	0

Recall history · 41 on record

Date	Class	Reason	Firm
Jun 4, 2026	II	CGMP Deviations	Amgen, Inc.
Jun 4, 2026	II	Presence of Foreign Substance.	Amgen, Inc.
Jun 4, 2026	II	CGMP Deviations	Amgen, Inc.
Jun 4, 2026	II	CGMP Deviations	Amgen, Inc.
Jun 4, 2026	II	Presence of Foreign Substance.	Amgen, Inc.
Sep 22, 2025	II	Lack of assurance of sterility.	RC Outsourcing, LLC
Aug 29, 2025	II	Lack of Assurance of Sterility	Fagron Compounding Services
Apr 21, 2025	II	CGMP Deviations; potential temperature excursions due to transit delays	Mckesson Medical-Surgical Inc. Corporate Office
Feb 27, 2025	II	Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.	Amgen, Inc.
Feb 27, 2025	II	Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.	Amgen, Inc.
Nov 6, 2024	II	Lack of Sterility Assurance	Tailstorm Health INC
Oct 2, 2023	II	Lack of Assurance of Sterility	Pine Pharmaceuticals, LLC
Mar 27, 2023	III	Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.	Pine Pharmaceuticals, LLC
May 2, 2022	II	Defective container: loose crimp defect, potential loss of container integrity.	Amgen, Inc.
Dec 6, 2021	II	Lack of Assurance of Sterility	Edge Pharma, LLC
Aug 30, 2019	II	Lack of assurance of sterility.	Pacifico National, Inc. dba AmEx Pharmacy
Aug 30, 2019	II	Lack of assurance of sterility.	Pacifico National, Inc. dba AmEx Pharmacy
Jun 12, 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
Jun 12, 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
Jun 12, 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
May 3, 2019	II	Lack of assurance of sterility	Avella of Deer Valley, Inc. Store 38
Apr 19, 2019	II	Defective Delivery System: difficult to express	Pacifico National, Inc. dba AmEx Pharmacy
Oct 31, 2018	II	Lack of Assurance of Sterility	Avella of Deer Valley, Inc. Store 38
Sep 13, 2017	II	Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.	Amgen, Inc.
Aug 15, 2017	II	Lack of Assurance of Sterility.	Bella Pharmaceuticals, Inc.
Aug 15, 2017	II	Lack of Assurance of Sterility.	Bella Pharmaceuticals, Inc.
Aug 4, 2017	II	Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.	Amgen, Inc.
Dec 15, 2016	II	Lack of Assurance of Sterility: Potential cracks in glass vials	Amgen, Inc.
Nov 4, 2015	II	Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.	Pine Pharmaceuticals, LLC
Nov 4, 2015	II	Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.	Pine Pharmaceuticals, LLC
Nov 4, 2015	II	Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.	Pine Pharmaceuticals, LLC
Nov 4, 2015	II	Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.	Pine Pharmaceuticals, LLC
Jan 20, 2015	I	Non-Sterility: Product tested positive for bacterial contamination.	Pacifico National, Inc. dba AmEx Pharmacy
Jan 20, 2015	I	Non-Sterility: Product tested positive for bacterial contamination.	Pacifico National, Inc. dba AmEx Pharmacy
Oct 6, 2014	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Oregon Compounding Centers, Inc. dba Creative Compounds
Oct 19, 2013	II	Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.	Specialty Medicine Compounding Pharmacy
Sep 17, 2013	II	Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.	Amgen, Inc.
Sep 9, 2013	II	Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.	Avella of Deer Valley, Inc.
Sep 5, 2013	II	Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.	Fallon Wellness Pharmacy Llc
Aug 26, 2013	II	Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.	Leiter's Pharmacy
Oct 4, 2010	II	Presence of Particulate Matter: glass delamination	Physicians Total Care, Inc.

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Amgen, Inc are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.