Libtayo (cemiplimab-rwlc) Injection
Regeneron recalls Libtayo (cemiplimab-rwlc) Injection 350 mg/7 mL over sterility concerns.
Consumers should stop using the recalled Libtayo (cemiplimab-rwlc) Injection and contact their healthcare provider or Regeneron Pharmaceuticals for guidance and replacement.
Recall at a glance
- Quantity recalled
- 21,353 vials
Why it was recalled
Regeneron Pharmaceuticals is recalling Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), single-dose vials for intravenous infusion due to a lack of assurance of sterility.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Libtayo (cemiplimab-rwlc) Injection
- Lot code
- 8494000002
- Strength
- 350 mg
- UPC
- 8494000002
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification