Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AMGEN Kyprolis (carfilzomib) for injection Recalled by Amgen, Inc. Due to Lack of Assurance of Sterility: Potential cracks in...

Date: December 15, 2016
Company: Amgen, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amgen, Inc. directly.

Affected Products

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

Quantity: 11,434 vials

Why Was This Recalled?

Lack of Assurance of Sterility: Potential cracks in glass vials

Where Was This Sold?

United States and Puerto Rico No foreign distribution.

About Amgen, Inc.

Amgen, Inc. has 7 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report