The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0621-2021·Announced 2021-04-21

Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

Novo Nordisk is recalling specific lots of TRESIBA insulin pens because they were stored below 32°F, which may reduce efficacy and damage the device.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it poses a reasonable probability of serious adverse health consequences or death due to lack of efficacy.

Plain-English summary

Novo Nordisk Inc is recalling specific lots of TRESIBA (insulin degludec) 200 units/mL (U-200) 3 mL Prefilled Pens. The recall is due to temperature abuse, where product samples were stored at temperatures below 32°F, which does not meet storage requirements.

This improper storage could cause a lack of efficacy in the insulin and damage to the cartridge and pen-injectors. The affected products are distributed nationwide in the USA.

Consumers should check their TRESIBA pens against the specific lot codes and expiration dates listed in the official recall notice. If a pen matches the recalled lots, it should not be used. Patients should contact their healthcare provider or Novo Nordisk for replacement or further instructions.

The recalled product

Product
TRESIBA (INSULIN DEGLUDEC)
Brand
TRESIBA
Manufacturer
Novo Nordisk Inc
Category
Drug — Insulin
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • KP52829 exp 07/31/2022
  • JP54181 exp 09/30/2021
  • KP51059 exp 11/30/2021
  • KP51865 exp 11/30/2021
  • KP54179 exp 11/30/2022
  • JP52179 exp 08/16/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Novo Nordisk Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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