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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Novo Nordisk Inc: Novo Nordisk Diabetes and Weight Loss Injections Recalled for Temperature Abuse

Agency Publication Date: April 15, 2021
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Summary

Novo Nordisk Inc. has recalled various sample-sized diabetes and weight loss medications, including Ozempic (semaglutide), Victoza (liraglutide), and multiple types of Tresiba and NovoLog insulin. These products were stored at temperatures below 32°F, which is outside of the required storage conditions. This temperature abuse can cause the medication to lose its effectiveness and can also physically damage the cartridges and pen-injectors. These products were distributed nationwide across the United States as clinical samples.

Risk

Storing these medications at freezing temperatures can alter the chemical structure of the drug, making it less effective or completely inactive, which could lead to poorly controlled blood sugar levels for patients. Additionally, the freezing process can cause the internal glass cartridges or the mechanical components of the pen-injectors to crack or fail, potentially leading to incorrect dosing or injury during use.

What You Should Do

  1. Check your medication packaging for the product name and NDC numbers, such as Ozempic (NDC 0169-4132-90/97), Tresiba (NDC 0169-2660-90/97), or Saxenda (NDC 0169-2800-90/97).
  2. Verify the lot number and expiration date on your pen or vial against the affected list, which includes Ozempic lots like KP50867 (Exp 10/31/2022) and KP53021 (Exp 04/30/2023), and Tresiba lot JZFE233 (Exp 11/30/2021).
  3. Immediately stop using any medication that matches the affected lot numbers and expiration dates provided in the recall list.
  4. Contact your healthcare provider or pharmacist immediately to discuss alternative medication options and to report any issues with your blood sugar control.
  5. Return any unused recalled product samples to your healthcare provider or the pharmacy where you received them for a refund or proper disposal.
  6. Contact Novo Nordisk Inc. for further instructions or to report any product-related concerns at their customer service line or through their official website.
  7. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare provider consultation and product return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Saxenda (liraglutide) Injection (18 mg/3 mL)
Model:
NDC 0169-2800-90 (Pen)
NDC 0169-2800-97 (Kit)
Lot Numbers:
K1620A1 (Kit)
KZFH714 (Pen) (Exp 05/31/2022)
B2020A (Kit)
JZFF482 (Pen) (Exp 11/30/2021)
I2320A (Kit)
H1020A (Kit)
J0520A (Kit)
Date Ranges: Exp 05/31/2022, Exp 11/30/2021
Product: TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100)
Model:
NDC 0169-2660-90 (Pen)
NDC 0169-2660-97 (Kit)
Lot Numbers:
JP52771 (Exp 09/30/2021)
JP53136 (Exp 06/30/2021)
KP50575 (Exp 01/31/2022)
KP50976 (Exp 01/31/2022)
KP51813 (Exp 04/30/2022)
KP52035 (Exp 04/30/2022)
KP52117 (Exp 04/30/2022)
KP52440 (Exp 06/30/2022)
KP52461 (Exp 04/30/2022)
KP52616 (Exp 06/30/2022)
JP52361 (Exp 08/01/2021)
Date Ranges: September 2021, June 2021, January 2022, April 2022, June 2022, August 2021
Product: TRESIBA (insulin degludec injection) 100 units/mL (U-100) 10 mL vial
Model:
NDC 0169-2662-90
Lot Numbers:
JZFE233 (Exp 11/30/2021)
Date Ranges: Exp 11/30/2021
Product: TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200)
Model:
NDC 0169-2550-90 (Pen)
0169-2550-97 (Kit)
Lot Numbers:
KP52829 (Exp 07/31/2022)
JP54181 (Exp 09/30/2021)
KP51059 (Exp 11/30/2021)
KP51865 (Exp 11/30/2021)
KP54179 (Exp 11/30/2022)
JP52179 (Exp 08/16/2021)
Date Ranges: July 2022, September 2021, November 2021, November 2022, August 2021
Product: ViCTOZA (liraglutide) injection (18 mg/3 mL)
Model:
NDC 0169-4060-90 (Pen)
0169-4060-99 (Kit)
Lot Numbers:
I2419A (Kit)
JS68K86 (Pen) (Exp 05/31/2021)
Date Ranges: Exp 05/31/2021
Product: Xultophy 100/3.6 (insulin degludec and liraglutide injection)
Model:
NDC 0169-2911-90 (Pen)
NDC 0169-2911-97 (Kit)
Lot Numbers:
JP54291 (Exp 06/20/2021)
Date Ranges: Exp 06/20/2021
Product: OZEMPIC (semaglutide) injection (2 mg/1.5 mL)
Model:
NDC 0169-4132-90 (Pen)
NDC 0169-4132-97 (Kit)
Lot Numbers:
KP50867 (Exp 10/31/2022)
KP53021 (Exp 04/30/2023)
KP52338 (Exp 02/28/2023)
JP54354 (Exp 08/31/2022)
KP50676 (Exp 10/31/2022)
KP51434 (Exp 11/30/2022)
KP51491 (Exp 11/30/2022)
KP51781 (Exp 01/31/2023)
KP52249 (Exp 01/31/2023)
KP52270 (Exp 01/31/2023)
KP52722 (Exp 01/31/2023)
KP52973 (Exp 01/31/2023)
KP53031 (Exp 01/31/2023)
KP53221 (Exp 12.04.2023)
KP53369 (Exp 01/31/2023)
Date Ranges: October 2022, April 2023, February 2023, August 2022, November 2022, January 2023, December 2023
Product: Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100)
Model:
NDC 0169-3204-90 (Pen)
NDC 0169-3204-97 (Kit)
Lot Numbers:
KP51207 (Exp 06/30/2022)
KP52618 (Exp 10/31/2022)
Date Ranges: June 2022, October 2022
Product: Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100) cartridges
Model:
NDC 0169-3205-91
Lot Numbers:
KS6BF84 (Exp 06/30/2022)
Date Ranges: Exp 06/30/2022
Product: Fiasp (insulin aspart injection) 100 units/mL (U-100) 10 mL vial
Model:
NDC 0169-3201-90
Lot Numbers:
KS6BX63 (Exp 10/31/2022)
KS6AK76 (Exp 05/31/2022)
KS6BR92 (Exp 09/30/2022)
Date Ranges: October 2022, May 2022, September 2022
Product: Levemir FlexTouch (insulin detemir) injection 100 units/mL (U-100)
Model:
NDC 0169-6438-90 (Pen)
NDC 0169-6438-98 (Kit)
Lot Numbers:
KP51933 (Exp 07/31/2022)
Date Ranges: Exp 07/31/2022
Product: NovoLog FlexPen (insulin aspart) Injection 100 units/mL
Model:
NDC 0169-6339-90 (Pen)
NDC 0169-6339-98 (Kit)
Lot Numbers:
KS6BS11 (Exp 11/30/2021)
Date Ranges: Exp 11/30/2021
Product: NovoLog (Insulin aspart) Injection 100 units/mL (U-100) 10 mL vial
Model:
NDC 0169-7501-90
Lot Numbers:
JZFC826 (Exp 06/30/2021)
KZFM305 (Exp 08/31/2022)
Date Ranges: June 2021, August 2022

Product Images

The batch numbers are printed on the product carton as indicated in the red box (e.g. the batch number is KP53230)

The batch numbers are printed on the product carton as indicated in the red box (e.g. the batch number is KP53230)

The red box shows where the batch number is located on the carton (e.g. the batch number is I2419A)

The red box shows where the batch number is located on the carton (e.g. the batch number is I2419A)

The batch numbers are also printed on the product. The red box shows where the batch number is located on the pen (e.g. the batch number is KP53230)

The batch numbers are also printed on the product. The red box shows where the batch number is located on the pen (e.g. the batch number is KP53230)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87537
Status: Resolved
Manufacturer: Novo Nordisk Inc
Sold By: Clinicians; Medical Samples; Healthcare Providers
Manufactured In: United States, Denmark
Distributed To: Nationwide
Agency Last Updated: June 10, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.