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Recall Observatory FDA recall evidence

Drug 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

D-0245-2026

December 19, 2025

Class II

Product summary

Firm
Novo Nordisk Inc.
Event
Event 98100
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0245-2026

Official wording

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

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

Distribution pattern: Nationwide within the United States.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter