CLASS II Drug recall · Reported 21 Apr 2021 · FDA Enforcement Report
Saxenda (liraglutide) Injection, 18 mg/ (6 mg/mL) recalled
Novo Nordisk is recalling Saxenda (liraglutide) Injection, 18 mg/ (6 mg/mL), mL Prefilled Pen, Sample kits, distributed nationwide in the US. The recall was initiated on 22 Mar 2021 and the FDA has classified it as Class II.
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-0618-2021
- FDA event ID
- 87537
- Recalling firm
- Novo Nordisk, Plainsboro, NJ
- Brand
- Saxenda
- Manufacturer
- Novo Nordisk Pharmaceutical Industries, LP
- Classification
- Class II
- 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
Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit)
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?
K1620A1 (Kit); KZFH714 (Pen) exp 05/31/2022; B2020A (Kit); JZFF482 (Pen) exp 11/30/2021; I2320A (Kit); KZFH714 (Pen) exp 05/31/2022; H1020A (Kit); KZFH714 (Pen) exp 05/31/2022; J0520A(Kit); KZFH714 (Pen) exp 05/31/2022
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 87537More 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 Liraglutide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | ViCTOZA (liraglutide) injection, 18 mg/ (6 mg/mL), contains recalledVictoza | Novo Nordisk | Temperature Abuse | Nationwide |