Regeneron Libtayo (cemiplimab-rwlc) Injection Recall
Announced 2026-08-26 · FDA
The FDA is recalling Regeneron Libtayo Injection due to lack of assurance of sterility. About 21,353 vials distributed nationwide in the United States are affected. The recall identifies Lot 8494000002.
| Brand | Regeneron Pharmaceuticals Inc |
|---|---|
| Product | 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 |
| Severity | moderate |
| Units affected | 21353 |
| Distribution | USA Nationwide |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any Regeneron Libtayo vials from the affected lot.
- If you have vials labeled Lot 8494000002, contact your healthcare provider or pharmacist for guidance on replacement or disposal.
- If you have already used the product or have concerns, contact your healthcare provider immediately.
- Follow disposal or return instructions from your healthcare provider, pharmacist, or the FDA recall page for more information.
How to identify the recalled item
| Lot / date codes | Lot: 8494000002, Exp 7/31/28 |
|---|---|
| Lot / date codes | Lot: 8494000002, Exp 7/31/28 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.