Prolia recalls

Prolia products have been recalled 3 times, most recently on 30 Jul 2025. The recalling company is usually Amgen.

Total recalls3since 2013

Last 12 months0reported

Class I00% of total

Ongoing1latest 30 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 1Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why prolia is recalled

Companies

Product types

Injectable & IV Drugs267%
Other133%

By year

2025133%
2023133%
2013133%

Ongoing prolia recalls

1 active

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025Drug	CLASS II	Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalledProlia	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	FL, VA

All prolia recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025Drug	CLASS II	Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalledProlia	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	FL, VA
10 May 2023Food	CLASS II	Prolia Soy Flr 200/20 Xtra Bg Ngm recalled by Cargill, Inc CorporateProlia	Cargill, Inc Corporate Headquarters	Other	Nationwide
13 Nov 2013Drug	CLASS II	Prolia (denosumab) Injection, 60 mg/mL recalled by AmgenProlia	Amgen	Particulate Matter	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.