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.
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 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
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 →Related recalls
Same brand · FIASP
- SevereNovo Nordisk Recalls Fiasp Insulin Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- SevereNovo Nordisk Recalls Fiasp Insulin Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
Same manufacturer · Novo Nordisk Inc
See all →- HighWegovy 0.5 mg pens recalled after hair was found in a syringe
FDA (Drugs) · 2026-01-07
- HighWegovy prefilled pens recalled after hair was found in a syringe
FDA (Drugs) · 2026-01-07
- ModerateNovo Nordisk Recalls OZEMPIC Injection Pens Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- SevereNovo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- SevereNovo Nordisk Recalls Insulin Diluting Medium Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
Same hazard · lack of efficacy
See all →- SevereNovo Nordisk Recalls TRESIBA Insulin Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- ModerateNovo Nordisk Recalls Victoza Injection Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- ModerateNovo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- SevereNovo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse
FDA (Drugs) · 2021-04-21