Cemiplimab Injection Recalled Due to Lack of Sterility Assurance

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Libtayo (cemiplimab-rwlc) injection, 50 mg/mL. The affected batch has been identified as Lot 8494000002 (expires July 2028), containing 21 353 vials.
• The recall was initiated by Regeneron Pharmaceuticals, Inc due to a lack of sterility assurance, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Cemiplimab is used to treat cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non–small cell lung cancer (NSCLC).

The FDA has issued a Class II recall for Libtayo (cemiplimab-rwlc) injection, 50 mg/mL, affecting 21 353 vials. This product is manufactured and is being recalled by Regeneron Pharmaceuticals, Inc based in Tarrytown, New York. The recall was initiated on July 28, 2026, and received a Class II classification on August 24, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the product’s lack of sterility assurance. This deficiency affects Lot 8494000002, which will expire in July 2028. Regeneron Pharmaceuticals sent out a public notice via letter; no press release has been issued for this recall.

Cemiplimab is used to treat various metastatic cancers that cannot be treated with surgery or radiation, including CSCC, BCC, and NSCLC. Pharmacists should identify and quarantine Lot 8494000002, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 26, 2026. Accessed August 26, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221737