TRESIBA FlexTouch (Novo Nordisk) – Temperature Storage Issue (2021)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit)
Brand
Novo Nordisk Inc
Lot Codes / Batch 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
Products Sold
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
Novo Nordisk Inc is recalling TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx due to Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lac. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026