Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200) Recalled by Novo Nordisk Inc Due to Temperature Abuse: product samples were stored at temperatures...

Date: March 22, 2021
Company: Novo Nordisk Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Novo Nordisk Inc directly.

Affected Products

TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)

Quantity: N/A

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Novo Nordisk Inc

Novo Nordisk Inc has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report