FDA recall, , Moderate risk
Libtayo (Cemiplimab-Rwlc) Injection
Libtayo (cemiplimab-rwlc) Injection lacks assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Regeneron Pharmaceuticals Inc, of Tarrytown, New York, is recalling Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, because of a lack of assurance of sterility. The company began the recall on July 28, 2026, and the product was distributed nationwide in the USA. The recall involves 21,353 vials of the product, which is manufactured and marketed by Regeneron Pharmaceuticals, Inc.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC or UPC is listed.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Libtayo (cemiplimab-rwlc) Injection
- NDC
- 61755-008-01
- UPC
- 8494000002
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Regeneron Pharmaceuticals IncTarrytown, New York
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99523
- Recall number
- D-0767-2026
- Quantity recalled
- 21,353 vials
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
