AMGEN Kyprolis — Class II drug recall D-0226-2017
Terminated recall by Amgen, Inc., reported 2016-12-28, distributed in PR. Lack of Assurance of Sterility: Potential cracks in glass vials
| Recall number | D-0226-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amgen, Inc., Thousand Oaks, CA, United States |
| Recall initiated | 2016-12-15 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-06-02 |
| Distributed | PR |
| Quantity | 11,434 vials |
| Reason classes | foreign material, sterility, packaging |
| NDC | 76075-0101, 76075-0101-01, 76075-0101-21, 76075-0102, 76075-0102-01, 76075-0102-21, 76075-0103, 76075-0103-01, 76075-0103-21 |
| Lot numbers | 05/18, 1071559, 1071629 |
Product
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
Reason for recall
Lack of Assurance of Sterility: Potential cracks in glass vials
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0226-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.