Denosumab recalls

The FDA has published 2 recalls involving Denosumab since 2013. The latest was reported on 30 Jul 2025. Most were for particulate matter. Mckesson Medical-Surgical Inc. Corporate Office has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 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 2 100%Class III 0 0%

Why denosumab is recalled

Particulate Matter150%
Manufacturing (CGMP) Deviations150%

Companies

By year

2025150%
2013150%

Ongoing denosumab 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 denosumab recalls, newest first

2 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
13 Nov 2013Drug	CLASS II	Prolia (denosumab) Injection, 60 mg/mL recalled by AmgenProlia	Amgen	Particulate Matter	Nationwide

Should you stop taking Denosumab?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.