Libtayo recall (Regeneron Pharmaceuticals Inc)
DrugClass IIOngoing
Summary: Regeneron Pharmaceuticals Inc is recalling 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. Reason: Lack of Assurance of Sterility.
What is being recalled
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
Why
Lack of Assurance of Sterility
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot: 8494000002, Exp 7/31/28
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0767-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 28, 2026 |
| Reported | August 26, 2026 |
| Company | Regeneron Pharmaceuticals Inc |
| Company location | Tarrytown, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 21,353 vials |
More recalls from Regeneron Pharmaceuticals Inc · all drug recalls · recalls from July 2026