Nivolumab recalls

The FDA has published 2 recalls involving Nivolumab since 2019. The latest was reported on 29 Oct 2025. Most were for sterility. Bristol-Myers Squibb 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 2019

Last 12 months1reported

Class I00% of total

Ongoing1latest 29 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 1Oct 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 nivolumab is recalled

Sterility2100%

Companies

Bristol-Myers Squibb150%
Infusion Options150%

By year

2025150%
2019150%

Ongoing nivolumab recalls

1 active

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Drug	CLASS II	Opdualag (nivolumab and relatlimab-rmbw) injection recalledOpdualag	Bristol-Myers Squibb	Sterility	Nationwide

All nivolumab recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Drug	CLASS II	Opdualag (nivolumab and relatlimab-rmbw) injection recalledOpdualag	Bristol-Myers Squibb	Sterility	Nationwide
21 Aug 2019Drug	CLASS II	Nivolumab 480 MG / Ns Ivpb recalled by Infusion Options	Infusion Options	Sterility	NY

Should you stop taking Nivolumab?

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.