Novo Nordisk Inc.
Overview
Novo Nordisk Inc. is a leading global healthcare company and a subsidiary of Novo Nordisk A/S. The company is renowned for its leadership in diabetes care and also provides therapies for obesity, hemophilia, growth disorders, and hormone replacement therapy.
Therapeutic areas
FDA compliance signals
23 FDA enforcement records linked to this company.
- warning_letter2026-03-05
FDA Warning Letter (drug product)
- recall — Class II2026-01-07
Presence of Particulate Matter: Hair was found in a prefilled syringe
- recall — Class II2026-01-07
Presence of Particulate Matter: Hair was found in a prefilled syringe
- warning_letter2025-09-09
FDA Warning Letter (drug product)
- 4832025-02-07
Late submission of an ICSR
- 4832025-02-07
Failure to develop written procedures
- 4832025-02-07
Late submission of 15-day report
- 4832025-02-07
Failure to investigate serious, unexpected events
- recall — Class I2021-04-21
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.
- recall — Class I2021-04-21
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.
- recall — Class I2021-04-21
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.
- recall — Class I2021-04-21
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.
- recall — Class I2021-04-21
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.
- recall — Class II2021-04-21
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.
- recall — Class II2021-04-21
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.
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