Novo Nordisk Inc

FDA Regulatory Profile

Summary

Total Recalls
18 (11 Class I)
510(k) Clearances
15
Inspections
34
Compliance Actions
3

Recent Recalls

NumberClassProductDate
D-0244-2026Class IIWegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo NDecember 19, 2025
D-0245-2026Class IIWegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo NorDecember 19, 2025
D-0621-2021Class ITRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx March 22, 2021
D-0611-2021Class IFiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not forMarch 22, 2021
D-0614-2021Class ILevemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx March 22, 2021
D-0613-2021Class IFiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for RMarch 22, 2021
D-0615-2021Class INovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, SampleMarch 22, 2021
D-0612-2021Class IFiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per packMarch 22, 2021
D-0617-2021Class IIOZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for ResaMarch 22, 2021
D-0618-2021Class IISaxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for ResalMarch 22, 2021
D-0623-2021Class IXultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL PrefMarch 22, 2021
D-0619-2021Class ITRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, RxMarch 22, 2021
D-0616-2021Class INovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not forMarch 22, 2021
D-0622-2021Class IIViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for ResalMarch 22, 2021
D-0620-2021Class ITRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not foMarch 22, 2021
Z-0206-2018Class IIDial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen July 5, 2017
D-0217-2017Class IGlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, MaSeptember 8, 2016
D-0956-2016Class IINorditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo NorApril 27, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K231255NovoFine® PlusAugust 25, 2023
K210258NovoFineJune 23, 2021
K202005NovoFine Plus 32G Tip x 4 mmDecember 19, 2020
K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)December 17, 2018
K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)January 17, 2018
K162602NovoPen EchoOctober 18, 2016
K150874NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)July 31, 2015
K133738NOVOFINE PLUS 32G 4 MMMay 21, 2014
K123766NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PENAugust 15, 2013
K093109NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')June 18, 2010
K090111FLEXPEN NEEDLEFebruary 1, 2010
K062500FLEXPEN NEEDLENovember 21, 2006
K053470NOVOFINE 32G TIPDecember 21, 2005
K050106NOVOFINE AUTOCOVER 30G X 8MMMarch 30, 2005
K010359INNOVOMarch 14, 2001