Home / Recalls / Novo Nordisk Inc. / D-0245-2026

D-0245-2026 Class II Ongoing

Recalled by Novo Nordisk Inc. — Plainsboro, NJ

FDA drug recall D-0245-2026 was initiated by Novo Nordisk Inc. on Dec 19, 2025 and is designated Class II. Reason for recall: Presence of Particulate Matter: Hair was found in a prefilled syringe The recall status is ongoing.

Recall Details

Product Type: Drugs
Report Date: Jan 7, 2026
Initiation Date: Dec 19, 2025
Voluntary/Mandated: Voluntary: Firm initiated

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

Distribution Pattern

Nationwide within the United States.

Code Information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0245-2026
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Novo Nordisk Inc.

D-0244-2026 Class II — Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens… (Dec 19, 2025)
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D-0619-2021 Class I — TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL… (Mar 22, 2021)
D-0621-2021 Class I — TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL… (Mar 22, 2021)
D-0622-2021 Class II — ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen… (Mar 22, 2021)
D-0618-2021 Class II — Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen… (Mar 22, 2021)
D-0611-2021 Class I — Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled… (Mar 22, 2021)
D-0617-2021 Class II — OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen… (Mar 22, 2021)
D-0614-2021 Class I — Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL… (Mar 22, 2021)
D-0615-2021 Class I — NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin… (Mar 22, 2021)