Nipocalimab-aahu recalls

The FDA has published 1 recall involving Nipocalimab-aahu since 2026. The latest was reported on 14 Oct 2026. Most were for particulate matter. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2026

Last 12 months1reported

Class I00% of total

Ongoing1latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 1

Severity split

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

Why nipocalimab-aahu is recalled

Particulate Matter1100%

Companies

J&J Innovative Medicine1100%

By year

20261100%

Ongoing nipocalimab-aahu recalls

1 active

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Imaavy (nipocalimab-aahu) Injection, 300 mg recalledImaavy	J&J Innovative Medicine	Particulate Matter	OH

All nipocalimab-aahu recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Imaavy (nipocalimab-aahu) Injection, 300 mg recalledImaavy	J&J Innovative Medicine	Particulate Matter	OH

Should you stop taking Nipocalimab-aahu?

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.