CLASS II Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
Kyprolis (carfilzomib) for injection, 30 mg per vial recalled by Amgen
Amgen is recalling Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For, distributed in Puerto Rico. The recall was initiated on 15 Dec 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0226-2017
- FDA event ID
- 76012
- Recalling firm
- Amgen, Thousand Oaks, CA
- Brand
- Kyprolis
- Manufacturer
- Onyx Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Dec 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Dec 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +7 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Potential cracks in glass vials
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
United States and Puerto Rico No foreign distribution.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Potential cracks in glass vials
Which lots are affected?
Lot #1071559, 1071629; Exp. 05/18
Where was it sold?
United States and Puerto Rico No foreign distribution.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS II | Corlanor (ivabradine) tablets, 5 mg recalled by AmgenCorlanor | Amgen | Packaging Defects | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 7.5mg recalled by AmgenCorlanor | Amgen | Other | Nationwide |
Other Carfilzomib recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carfilzomib 65 MG In D5w Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |