The Recall Desk
SevereFDA (Drugs)·D-0619-2021·Announced 2021-04-21

Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

Novo Nordisk is recalling TRESIBA (insulin degludec) prefilled pens because they were stored below 32°F, which may reduce efficacy and damage the device.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls are assigned a minimum score of 4 (Severe) due to the potential for serious adverse health consequences, even if specific injuries are not yet reported in the text.

Plain-English summary

Novo Nordisk Inc is recalling TRESIBA (insulin degludec) 100 units/mL (U-100) 3 mL Prefilled Pens, including samples, due to temperature abuse. The product was stored at temperatures below 32°F, which does not meet storage requirements. This condition could cause a lack of efficacy and damage to the cartridge and pen-injectors.

The recall covers specific lots distributed nationwide in the USA. Affected lot numbers include JP52771, JP53136, KP50575, KP50976, KP51813, KP52035, KP52117, KP52440, KP52461, KP52616, and JP52361. The expiration dates for these lots range from August 1, 2021, to June 30, 2022.

Consumers and healthcare providers should stop using the affected TRESIBA pens and contact their healthcare provider or Novo Nordisk for replacement or further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.

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 (11)

  • JP52771 exp 09/30/2021
  • JP53136 exp 06/30/2021
  • KP50575 exp 01/31/2022
  • KP50976 exp 01/31/2022
  • KP51813 exp 04/30/2022
  • KP52035 exp 04/30/2022
  • KP52117 exp 04/30/2022
  • KP52440 exp 06/30/2022
  • KP52461 exp 04/30/2022
  • KP52616 exp 06/30/2022
  • JP52361 exp 08/01/2021

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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