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  4. Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions
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COMPANY ANNOUNCEMENT

Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Due to improper storage temperature conditions
Company Name:
Novo Nordisk
Brand Name:
Brand Name(s)
Levemir, Tresiba, Fiasp, Novolog and Xultophy
Product Description:
Product Description
Product Samples

Company Announcement

Novo Nordisk is voluntarily recalling 1,468 product samples listed in the table below of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements. This recall only impacts product samples and does not impact product that has been broadly distributed to pharmacies or mail-order services.

If product samples are exposed to temperatures below 32°F, it could cause a lack of efficacy and damage to the cartridge and pen-injectors. If product from an improperly stored vial, cartridge or pen-injector is used, there is a risk that you might not receive the right amount of medicine as intended which may lead to hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening. Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall.

These products are used to lower blood glucose levels in people with diabetes and are packaged in cartons with either a vial, pen-injector (FlexPen® or FlexTouch®) or a cartridge (PenFill®). A list of the affected lots can be found in the chart below:

Product Name NDC # Batch # # of Affected
Samples
Expiration
Date
Fiasp® FlexTouch® 0169-3204-90 (Pen)
0169-3204-97 (Kit)
KP51207
---------------
KP52618
24
---------------
153
6/30/2022
---------------
10/31/2022
Fiasp® PenFill® 0169-3205-91 KS6BF84 7 6/30/2022
Fiasp® Vial 0169-3201-90 KS6BX63
---------------
KS6AK76
---------------
KS6BR92
90
---------------
10
---------------
20
10/31/2022
5/31/2022
9/30/2022
Levemir® FlexTouch® 0169-6438-90 (Pen)
0169-6438-98 (Kit)
KP51933 24 7/31/2022
NovoLog® FlexPen® 0169-6339-90 (Pen)
0169-5339-98 (Kit)
KS6BS11 44 11/30/2021
NovoLog® Vial 0169-7501-90 JZFC826
---------------
KZFM305
17
---------------
26
6/30/2021
---------------
8/31/2022
Tresiba® U100 FlexTouch® 0169-2660-90 (Pen)
0169-2660-97 (Kit)
JP52771
---------------
JP53136
---------------
KP50575
---------------
KP50976
---------------
KP51813
---------------
KP52035
---------------
KP52117
---------------
KP52440
---------------
KP52461
---------------
KP52616
---------------
JP52361
13
---------------
4
---------------
30
---------------
27
---------------
99
---------------
12
---------------
36
---------------
207
---------------
60
---------------
81
---------------
7
9/30/2021
---------------
6/30/2021
---------------
1/31/2021
---------------
1/31/2022
---------------
4/30/2022
---------------
4/30/2022
---------------
4/30/2022
---------------
6/30/2022
---------------
4/30/2022
---------------
6/30/2022
---------------
8/1/2021
Tresiba® U200 FlexTouch® 0169-2550-90 (Pen)
0169-2550-97 (Kit)
KP52829
---------------
JP54181
---------------
KP51059
---------------
KP51865
---------------
KP54179
---------------
JP52179
170
---------------
12
---------------
8
---------------
182
---------------
68
---------------
20
7/31/2022
---------------
9/30/2021
---------------
11/30/2021
---------------
11/30/2021
---------------
11/30/2022
---------------
8/16/2021
Tresiba® Vial 0169-2662-90 JZFE233 14 11/30/2021
Xultophy® Pen 0169-2911-90 (Pen)
0169-2911-97 (Kit)
JP54291 3 6/20/2021

The product can be identified by looking for the batch number or lot number located on the product or carton and matching it to the list above. Novo Nordisk has notified all physician offices that received affected samples and requested all impacted samples be returned. Customers who received an affected sample through the physician's office should have received a letter from their physician. If product samples match a batch number above or there are any questions about the recall, please contact the Novo Nordisk recall processor Inmar at 1-888-686-5002, Monday through Friday, 9:00 AM to 5:00 PM EDT.

Please report any complaints and adverse events to Novo Nordisk's Customer Care Center which can be reached at 1-800-727-6500, Monday through Friday, 8:30 AM to 6:00 PM EDT.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Novo Nordisk recall processor Inmar
1-888-686-5002

Product Photos

 
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