Drug recall
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution…
FDA recall event 99523 · Class II · Regeneron Pharmaceuticals Inc
Key facts
| Event ID | 99523 |
|---|---|
| Recall numbers | D-0767-2026 |
| Recalling firm | Regeneron Pharmaceuticals Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility |
| Initiation date | Jul 28, 2026 |
| Report date | Aug 26, 2026 |
| City | Tarrytown |
| State | NY |
| Country | United States |
| FEI number | 1000521995 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: