The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0611-2021·Announced 2021-04-21

Novo Nordisk Recalls Fiasp Insulin Pens Due to Temperature Abuse

Novo Nordisk is recalling Fiasp insulin pen samples stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

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.

Plain-English summary

Novo Nordisk Inc is recalling Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. The recall involves specific product codes KP51207 (exp 06/30/2022) and KP52618 (exp 10/31/2022). The product is distributed nationwide in the USA.

The recall is due to temperature abuse, as the product samples were 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.

Consumers should check their Fiasp insulin pen samples for the affected lot codes and expiration dates. If the product matches the recalled items, consumers should stop using it and contact their healthcare provider or Novo Nordisk for further instructions.

The recalled product

Product
FIASP (INSULIN ASPART INJECTION)
Brand
FIASP
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 (2)

  • KP51207 exp 06/30/2022
  • KP52618 exp 10/31/2022

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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