Belimumab recalls

The FDA has published 1 recall involving Belimumab since 2025. The latest was reported on 30 Jul 2025. Most were for manufacturing (cgmp) deviations. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2025

Last 12 months0reported

Class I00% of total

Ongoing1latest 30 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 1 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why belimumab is recalled

Manufacturing (CGMP) Deviations1100%

Companies

Mckesson Medical-Surgical Inc. Corporate Office1100%

By year

20251100%

Ongoing belimumab recalls

1 active

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025Drug	CLASS II	Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	FL, VA

All belimumab recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025Drug	CLASS II	Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	FL, VA

Should you stop taking Belimumab?

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.