Novo Nordisk Recalls Fiasp Insulin Due to Temperature Abuse
Novo Nordisk is recalling Fiasp insulin cartridges stored below 32°F, which 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 recall is classified as FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Novo Nordisk Inc is recalling Fiasp (insulin aspart injection) 100 units/mL (U-100) cartridges. The recall involves specific samples identified by the code KS6BF84 with an expiration date of 06/30/2022. The product is distributed nationwide in the USA.
The recall was initiated because product samples were stored at temperatures below 32°F, which does not meet storage requirements. This temperature abuse could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Consumers who possess the affected product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class I by the FDA.
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)
- KS6BF84
- Exp 06/30/2022
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 Pens 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 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
- 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 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