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Novo Nordisk Inc

Complete recall history across all FDA and CPSC categories — 16 total recalls

Recall Summary

15 Drug Recalls 1 Device Recalls

Novo Nordisk Inc appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (15)

FDA drug safety enforcement actions by Novo Nordisk Inc

Date Product Reason Class
Mar 22, 2021 TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Pre... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dos... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Pre... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefill... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose ... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Pre... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL a... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-do... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pe... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class II
Mar 22, 2021 OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pe... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class II
Mar 22, 2021 NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insu... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class I
Mar 22, 2021 Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen... Temperature Abuse: product samples were stored at temperatures below 32* F wh... Class II
Sep 8, 2016 GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Singl... Defective delivery system: detached needles on the syringe in the kit. Class I
Apr 27, 2016 Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled ... Defective Delivery System; may have a low frequency assembly fault which may ... Class II

Device Recalls (1)

FDA medical device enforcement actions by Novo Nordisk Inc

Date Product Reason Class
Jul 5, 2017 Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Produ... A small number of batches may crack or break if exposed to certain chemicals,... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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