Class II โ€” Potential Health Hazard

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

PROLIA (denosumab) Recalled by Mckesson Medical-Surgical Inc. Corporate Office Due to CGMP Deviations; potential temperature excursions due to transit...

Date: April 21, 2025
Company: Mckesson Medical-Surgical Inc. Corporate Office
Status: Ongoing
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 Mckesson Medical-Surgical Inc. Corporate Office directly.

Affected Products

PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

Quantity: 6 Pre-filled syringes

Why Was This Recalled?

CGMP Deviations; potential temperature excursions due to transit delays

Where Was This Sold?

This product was distributed to 3 states: FL, OH, VA

Affected (3 states)Not affected

About Mckesson Medical-Surgical Inc. Corporate Office

Mckesson Medical-Surgical Inc. Corporate Office has 276 total recalls tracked by RecallDetector.

Related Recalls

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