FDA Closes Recall of Regeneron's Libtayo Injection Over Sterility Assurance
The FDA has closed the Class II recall of Libtayo (cemiplimab-rwlc) Injection, lot 8494000002, initiated by Regeneron Pharmaceuticals over lack of assurance of sterility.
2 reports on this incident · first at Sep 7, 2026, 7:47 p.m. ET
Earlier reports
Sep 7, 2026, 7:47 p.m. ETFirst report
Regeneron Recalls Libtayo Injection Over Sterility Assurance
Regeneron Pharmaceuticals Inc. initiated a recall of Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), single-dose vials, due to a lack of assurance of sterility, according to an FDA enforcement report dated August 26, 2026. The recall, numbered D-0767-2026, covers 21,353 vials distributed nationwide in the USA. The affected lot is 8494000002, with an expiration date of 7/31/28. The recall was initiated on July 28, 2026, and is ongoing.
The FDA has classified this as a Class II recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The product is a prescription biological drug used for intravenous infusion after dilution, typically administered in healthcare settings such as hospital pharmacies and specialty clinics.
The FDA enforcement report lists Regeneron Pharmaceuticals Inc., Tarrytown, NY, as the manufacturer and marketer. The FDA database records no other enforcement action by this firm. The recall is ongoing, and the FDA advises that the cause of the sterility issue has not been determined.
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- Version 17 Sept 2026, 23:47current
First published.
- Version 17 Sept 2026, 23:54current
First published.
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