FDAFDA recall D-0767-2026 · Aug 26, 2026
Regeneron Pharmaceuticals Inc: Libtayo (cemiplimab-rwlc) Injection recall
Recall found
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 for recall
Lack of Assurance of Sterility
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot: 8494000002, Exp 7/31/28
- Quantity
- 21,353 vials
- Distribution
- USA Nationwide
- Recalling firm
- Regeneron Pharmaceuticals Inc, Tarrytown, NY
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-28
Source: openFDA enforcement record D-0767-2026 · search recall number D-0767-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.