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Novo Nordisk Inc. FDA Recalls

15 recalls on file across drugs, 10 of them Class I and 2 still open. Matched by name to NVO.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Class IIDec 19, 2025Presence of Particulate Matter: Hair was found in a prefille	Presence of Particulate Matter: Hair was found in a prefilled syringe	Class IIDrugs	Dec 19, 2025
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 BaClass IIDec 19, 2025Presence of Particulate Matter: Hair was found in a prefille	Presence of Particulate Matter: Hair was found in a prefilled syringe	Class IIDrugs	Dec 19, 2025
Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo NoClass IIMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IIDrugs	Mar 22, 2021
TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured Class IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021
OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo NoClass IIMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IIDrugs	Mar 22, 2021
ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, ManufactClass IIMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IIDrugs	Mar 22, 2021
NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, MaClass IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021
TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured bClass IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021
Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Class IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021
Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, RClass IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021
TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, MClass IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021
Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, ManuClass IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021
NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, RxClass IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021
Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, MaClass IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021
Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured bClass IMar 22, 2021Temperature Abuse: product samples were stored at temperatur	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto	Class IDrugs	Mar 22, 2021

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