Regeneron Pharmaceuticals Inc: Libtayo (cemiplimab-rwlc) Injection, 350 Mg/7 Ml (50 Mg/ml), For Intravenous Infusion After Dilution, Single-dose Vial
Regeneron Pharmaceuticals is recalling Libtayo (cemiplimab-rwlc) injection in the 350 mg vial strength nationwide because the company cannot guarantee the product is sterile. This recall affects the drug used to treat certain types of cancer and applies to all U.S. states and Washington, DC.
- Recalling firm
- 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
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-28
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/4d9d37d3-1b2a-47b8-b32d-47d8dda267ec