CLASS I Drug recall · Reported 21 Apr 2021 · FDA Enforcement Report
Fiasp (insulin aspart injection)/mL (U-100) recalled by Novo Nordisk
Novo Nordisk is recalling Fiasp (insulin aspart injection)/mL (U-100), One multi-dose vial, Sample, distributed nationwide in the US. The recall was initiated on 22 Mar 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0613-2021
- FDA event ID
- 87537
- Recalling firm
- Novo Nordisk, Plainsboro, NJ
- Brand
- Fiasp
- Manufacturer
- Novo Nordisk
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 22 Mar 2021
- FDA classified
- 10 Jun 2021
- Reported
- 21 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Diabetes Medication
Timeline
| 22 Mar 2021 | Recall initiated by company | |
| 21 Apr 2021 | Published in enforcement report | +30 days |
| 10 Jun 2021 | Classified by FDA | +50 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3201-90
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Which lots are affected?
KS6BX63 exp 10/31/2022; KS6AK76 exp 05/31/2022; KS6BR92 exp 09/30/2022
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 87537This product is part of a recall event; the main page for the event is Saxenda (liraglutide) Injection, 18 mg/ (6 mg/mL) recalled.
More recalls from Novo Nordisk
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Wegovy (semaglutide) Injection, 0.5 mg/-Dose Prefilled Pens recalled | Novo Nordisk | Particulate Matter | Nationwide |
| Drug | CLASS II | Wegovy (semaglutide) Injection, 1 mg/-Dose Prefilled Pens recalled | Novo Nordisk | Particulate Matter | Nationwide |
| Drug | CLASS I | Tresiba FlexTouch (insulin degludec injection)/mL recalledTresiba | Novo Nordisk | Temperature Abuse | Nationwide |
| Drug | CLASS I | NovoLog (Insulin aspart) Injection/mL (U-100) recalled by Novo NordiskInsulin Diluting Medium For Novolog | Novo Nordisk | Temperature Abuse | Nationwide |
| Drug | CLASS I | Tresiba FlexTouch (insulin degludec injection)/mL recalledTresiba | Novo Nordisk | Temperature Abuse | Nationwide |
Other Insulin Aspart recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Fiasp FlexTouch (insulin aspart injection)/mL recalled by Novo NordiskFiasp | Novo Nordisk | Temperature Abuse | Nationwide |
| Drug | CLASS I | Fiasp PenFill (insulin aspart injection)/mL recalled by Novo NordiskFiasp | Novo Nordisk | Temperature Abuse | Nationwide |