FDA Drug recall D-0767-2026
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactur…
- FDA Drug
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactur… by Regeneron Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0767-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-28 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Regeneron Pharmaceuticals |
| Distribution | US |
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
Identifiers
| ndc | 61755-008-01 |
|---|---|
| ndc | 8494000002 |
| code_info | Lot: 8494000002, Exp 7/31/28 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0767-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.