Cemiplimab-rwlc recalls

The FDA has published 1 recall involving Cemiplimab-rwlc since 2026. The latest was reported on 26 Aug 2026. Most were for sterility. 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 26 Aug 2026

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 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 1 0

Severity split

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

Why cemiplimab-rwlc is recalled

Sterility1100%

Companies

Regeneron Pharmaceuticals1100%

By year

20261100%

Ongoing cemiplimab-rwlc recalls

1 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Libtayo (cemiplimab-rwlc) Injection, 350 mg/ (50 mg/mL) recalledLibtayo	Regeneron Pharmaceuticals	Sterility	Nationwide

All cemiplimab-rwlc recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Libtayo (cemiplimab-rwlc) Injection, 350 mg/ (50 mg/mL) recalledLibtayo	Regeneron Pharmaceuticals	Sterility	Nationwide

Should you stop taking Cemiplimab-rwlc?

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.