First published 9/27/2026, 6:02:15 AM · Last updated 9/27/2026, 6:48:04 PM

Class II FDA drug recall: Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01

Class II FDA drug recall: Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01. Additional details were not included in the source data received by Planet Briefing.

Categories: public-health

Generated scores

Scores are based on the cited reporting and use a 1–10 scale. Read the methodology.

Confidence: 2/10How certain the assessment is based on the clarity and evidence in the cited reporting.
Geographic reach: 4/10How widely the event reaches, from a local area (1) to worldwide impact (10).
Global importance: 4/10The event's broader significance, from limited importance (1) to major global importance (10).
Impact magnitude: 3/10The scale or severity of the real-world impact, from minor (1) to extreme (10).
Positivity: 2/10How harmful or beneficial the event is, from strongly harmful (1) to strongly positive (10).
Urgency: 4/10How time-sensitive the event is, from low urgency (1) to immediate attention needed (10).

Why it matters

Additional impact information was not included in the source data received by Planet Briefing.

Location

Sources

Class II FDA drug recall: Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01

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