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Novo Nordisk Inc

FDA Regulatory Profile

Novo Nordisk Inc appears in FDA public data with 18 recalls — including 11 Class I (most serious) —, 15 510(k) clearances, 43 FDA inspections, and 3 compliance actions on record. Its most recent recall (D-0244-2026, Class II) was initiated on December 19, 2025. Its most recent 510(k) clearance was granted on August 25, 2023.

Summary

Total Recalls
18 (11 Class I)
510(k) Clearances
15
Inspections
43
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-0619-2021Class ITRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, RxMarch 22, 2021
D-0621-2021Class ITRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx March 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-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-0613-2021Class IFiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for RMarch 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-0612-2021Class IFiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per packMarch 22, 2021
D-0615-2021Class INovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, SampleMarch 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-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-0614-2021Class ILevemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx March 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-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

FDA data resources