Novo Nordisk recalls

Novo Nordisk appears in 18 official U.S. recall notices indexed by RecallRadar, most recently on 2026-01-07.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark,…
  FDA Drug · Class II · 2026-01-07 · Novo Nordisk
  Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe
• Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, P…
  FDA Drug · Class II · 2026-01-07 · Novo Nordisk
  Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe
• Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Ma…
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S…
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample
  FDA Drug · Class II · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S…
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordi…
  FDA Drug · Class II · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample
  FDA Drug · Class II · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufacture…
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S…
  FDA Drug · Class I · 2021-04-21 · Novo Nordisk
  Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
• Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for singl…
  FDA Device · Class II · 2017-12-13 · Novo Nordisk
  Reason: A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
• GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Ba…
  FDA Drug · Class I · 2016-12-28 · Novo Nordisk
  Reason: Defective delivery system: detached needles on the syringe in the kit.
• Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7…
  FDA Drug · Class II · 2016-06-15 · Novo Nordisk
  Reason: Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step