Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo ...

FDA Recall #D-0245-2026 — Class II — December 19, 2025

Recall #D-0245-2026 Date: December 19, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

Presence of Particulate Matter: Hair was found in a prefilled syringe

Recalling Firm

Novo Nordisk Inc. — Plainsboro, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

Nationwide within the United States.

Code Information

Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated