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Novo Nordisk Inc

FDA Regulatory Profile

Novo Nordisk Inc has 18 FDA recalls (11 Class I), 44 inspections, 15 510(k) clearances and 3 compliance actions on record.

Latest recall
D-0244-2026 · Class II · Dec 19, 2025
Latest inspection
Apr 17, 2026 · VAI
Latest 510(k)
Aug 25, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls18 (11 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances15Nov 8, 2026File dated Nov 2, 2026Current
Inspections44Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions3Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

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

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 17, 2026Malov, DenmarkDrugsVoluntary Action Indicated (VAI)3003037054
Jan 23, 2026Soborg, DenmarkDrugsNo Action Indicated (NAI)3009341839
Jun 10, 2025Kalundborg, DenmarkDrugsVoluntary Action Indicated (VAI)3002807751
Feb 7, 2025Plainsboro, NJDrugsOfficial Action Indicated (OAI)2244771
Oct 3, 2024Bagsvard, DenmarkDrugsVoluntary Action Indicated (VAI)3000151819
Nov 17, 2023Soborg, DenmarkDrugsNo Action Indicated (NAI)3009341839
May 4, 2023Kalundborg, DenmarkBiologicsVoluntary Action Indicated (VAI)3002807751
Mar 29, 2023Bagsvard, DenmarkDrugsVoluntary Action Indicated (VAI)3000151819
Dec 21, 2022Plainsboro, NJDrugsNo Action Indicated (NAI)2244771
Dec 2, 2022Kalundborg, DenmarkDrugsVoluntary Action Indicated (VAI)3002807751
Jun 16, 2022Malov, DenmarkDrugsVoluntary Action Indicated (VAI)3003037054
May 12, 2021Malov, DenmarkDrugsVoluntary Action Indicated (VAI)3003037054
Dec 5, 2019Bagsvard, DenmarkDrugsVoluntary Action Indicated (VAI)3000151819
Sep 6, 2019Kalundborg, DenmarkDrugsNo Action Indicated (NAI)3002807751
Jun 1, 2018Malov, DenmarkDrugsNo Action Indicated (NAI)3003037054
May 18, 2018Bagsvard, DenmarkDrugsNo Action Indicated (NAI)3000151819
Nov 10, 2017Soborg, DenmarkDrugsNo Action Indicated (NAI)3009341839
Aug 29, 2017Kalundborg, DenmarkDrugsNo Action Indicated (NAI)3002807751
Jun 15, 2017Soborg, DenmarkDrugsNo Action Indicated (NAI)3009341839
Apr 13, 2017Plainsboro, NJDrugsVoluntary Action Indicated (VAI)2244771

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3003037054Malov, Denmark7Apr 17, 2026
FEI 3009341839Soborg, Denmark6Jan 23, 2026
FEI 3002807751Kalundborg, Denmark10Jun 10, 2025
FEI 2244771Plainsboro, NJ10Feb 7, 2025
FEI 3000151819Bagsvard, Denmark10Oct 3, 2024
FEI 3004547341Hjorring, Denmark1Mar 21, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K231255NovoFine® PlusAug 25, 2023
K210258NovoFineJun 23, 2021
K202005NovoFine Plus 32G Tip x 4 mmDec 19, 2020
K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Dec 17, 2018
K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)Jan 17, 2018
K162602NovoPen EchoOct 18, 2016
K150874NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Jul 31, 2015
K133738NOVOFINE PLUS 32G 4 MMMay 21, 2014
K123766NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PENAug 15, 2013
K093109NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')Jun 18, 2010
K090111FLEXPEN NEEDLEFeb 1, 2010
K062500FLEXPEN NEEDLENov 21, 2006
K053470NOVOFINE 32G TIPDec 21, 2005
K050106NOVOFINE AUTOCOVER 30G X 8MMMar 30, 2005
K010359INNOVOMar 14, 2001

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.