Amgen, Inc.

FDA recalling firm · 7 enforcement events · 12 product records · 2013–2026 · CA

Amgen, Inc. has 7 FDA enforcement events on this register (12 product records) between 2013 and 2026: 7 drug; the busiest year was 2017 with 2.

0% of its events are Class I; the most common class is Class II (7). 2 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
4 Jun 2026	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 Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.	Drug	Class II	5	Ongoing
27 Feb 2025	Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box).	Drug	Class II	2	Ongoing
2 May 2022	MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01	Drug	Class II	1	Terminated
13 Sep 2017	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 vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044	Drug	Class II	1	Terminated
4 Aug 2017	Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01	Drug	Class II	1	Terminated
15 Dec 2016	AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01	Drug	Class II	1	Terminated
17 Sep 2013	Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.	Drug	Class II	1	Terminated

By type and class

Drug7

Class II7

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Amgen, Inc. by year initiated.

Questions and answers

How many FDA recalls has Amgen, Inc. had?

7 enforcement events (12 product records) on this register, 2013–2026: 7 drug.

Are any Amgen, Inc. recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Amgen, Inc. recalls?

7 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.