Recall Enforment Report D-0245-2026

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Novo Nordisk Inc., originally initiated on 12-19-2025 for the product Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14 The product was recalled due to presence of particulate matter: hair was found in a prefilled syringe. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0245-202612-19-202501-07-2026Class IIN/AWegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14Presence of Particulate Matter: Hair was found in a prefilled syringeOngoing
D-0244-202612-19-202501-07-2026Class IIN/AWegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14Presence of Particulate Matter: Hair was found in a prefilled syringeOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0169-4404Wegovy SemaglutideTabletOralNovo NordiskHuman Prescription Drug
0169-4409Wegovy SemaglutideTabletOralNovo NordiskHuman Prescription Drug
0169-4415Wegovy SemaglutideTabletOralNovo NordiskHuman Prescription Drug
0169-4425Wegovy SemaglutideTabletOralNovo NordiskHuman Prescription Drug
0169-4501Wegovy SemaglutideInjection, SolutionSubcutaneousNovo NordiskHuman Prescription Drug
0169-4505Wegovy SemaglutideInjection, SolutionSubcutaneousNovo NordiskHuman Prescription Drug
0169-4517Wegovy SemaglutideInjection, SolutionSubcutaneousNovo NordiskHuman Prescription Drug
0169-4524Wegovy SemaglutideInjection, SolutionSubcutaneousNovo NordiskHuman Prescription Drug
0169-4525Wegovy SemaglutideInjection, SolutionSubcutaneousNovo NordiskHuman Prescription Drug