US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Apr 21, 2025 (17 months ago)

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations; potential temperature excursions due to transit delays

What was recalled

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
NDC code
55513-880-02
Origin
VA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0539-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.