Infliximab-dyyb recalls

The FDA has published 1 recall involving Infliximab-dyyb since 2025. The latest was reported on 5 Feb 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 5 Feb 2025

Recalls per month, last 24 months

click a bar for that month

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

Severity split

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

Why infliximab-dyyb is recalled

Manufacturing (CGMP) Deviations1100%

Companies

McKesson1100%

By year

20251100%

Ongoing infliximab-dyyb recalls

1 active

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Drug	CLASS II	Inflectra (infliximab-dyyb), For injection, 100mg per vial recalledInflectra	McKesson	Manufacturing (CGMP) Deviations	Nationwide

All infliximab-dyyb recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Drug	CLASS II	Inflectra (infliximab-dyyb), For injection, 100mg per vial recalledInflectra	McKesson	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Infliximab-dyyb?

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.