Novo Nordisk Inc recalls Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo
Novo Nordisk recalls Saxenda (liraglutide) samples due to improper cold storage causing potential product damage. Affected samples were stored below 32°F, risking cartridge and pen-injector damage.
Lower-risk 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.
Contact the company & request your remedy
What happened, in plain English
Novo Nordisk is recalling Saxenda (liraglutide) injection samples that were stored at temperatures below 32°F. This improper storage could damage the cartridge and pen-injector, making the product ineffective or unsafe to use. Read more at govinfonow.com/recall/36251-novo-nordisk-saxenda-sample-recall-temperature-storage-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/36251-novo-nordisk-saxenda-sample-recall-temperature-storage-issues · Updated October 4, 2026 · FDA enforcement record: FDA #D-0618-2021
Cite this page
“Novo Nordisk Saxenda Sample Recall: Temperature Storage Issues.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36251-novo-nordisk-saxenda-sample-recall-temperature-storage-issues. Based on FDA recall #D-0618-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0618-2021%22&limit=1).
Why it’s dangerous
The samples were stored at temperatures below 32°F, which is below the required storage conditions. This could cause the product to become ineffective and damage the cartridge and pen-injector.
Who’s affected
People who own or use the recalled Saxenda sample injections are affected. Those who stored the samples below 32°F are at higher risk of product damage.
How to tell if you have this one
Check for Saxenda (liraglutide) injection samples with the following identifiers: 1 x 3 mL Prefilled Pen, Sample. Not for resale. NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit), or specific batch codes like K1620A1 (Kit).
- Brand
Novo Nordisk- Category
Drug
All 13 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Class | NDC |
|---|---|---|---|
| D-0611-2021 | Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-3204-90 (Pen), NDC 0169-3204-97 (Kit); KP51207 exp 06/30/2022; KP52618 exp 10/31/2022 | Class I | 0169-3201-11, 0169-3201-90, 0169-3204-15, 0169-3204-90, 0169-3204-97, 0169-3205-11, 0169-3205-15, 0169-3205-91, 0169-3205-95, 0169-3206-11, 0169-3206-15, 0169-3206-91, 0169-3206-95 |
| D-0612-2021 | Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91; KS6BF84, Exp 06/30/2022 | Class I | 0169-3201-11, 0169-3201-90, 0169-3204-15, 0169-3204-90, 0169-3204-97, 0169-3205-11, 0169-3205-15, 0169-3205-91, 0169-3205-95, 0169-3206-11, 0169-3206-15, 0169-3206-91, 0169-3206-95 |
| D-0613-2021 | Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3201-90; KS6BX63 exp 10/31/2022; KS6AK76 exp 05/31/2022; KS6BR92 exp 09/30/2022 | Class I | 0169-3201-11, 0169-3201-90, 0169-3204-15, 0169-3204-90, 0169-3204-97, 0169-3205-11, 0169-3205-15, 0169-3205-91, 0169-3205-95, 0169-3206-11, 0169-3206-15, 0169-3206-91, 0169-3206-95 |
| D-0614-2021 | Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6438-90 (Pen), NDC 0169-6438-98 (Kit); KP51933 exp 07/31/2022 | Class I | 0169-3687-12, 0169-3687-92, 0169-6438-10, 0169-6438-90, 0169-6438-97, 0169-6438-98, 0169-6432-55, 0169-6432-10 |
| D-0615-2021 | NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit); KS6BS11, Exp 11/30/2021 | Class I | 0169-7501-11, 0169-7501-90, 0169-3303-12, 0169-3303-91, 0169-3303-90, 0169-6339-10, 0169-6339-90, 0169-6339-97, 0169-6339-98, 0169-6338-10, 0169-6338-90, 0169-6338-97, 0169-2001-90, 0169-2100-11, 0169-2101-12, 0169-2101-25 |
| D-0616-2021 | NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90; JZFC826 exp 06/30/2021; KZFM305 exp 08/31/2022 | Class I | 0169-7501-11, 0169-7501-90, 0169-3303-12, 0169-3303-91, 0169-3303-90, 0169-6339-10, 0169-6339-90, 0169-6339-97, 0169-6339-98, 0169-6338-10, 0169-6338-90, 0169-6338-97, 0169-2001-90, 0169-2100-11, 0169-2101-12, 0169-2101-25 |
| D-0617-2021 | OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit); 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 | Class II | — |
| D-0618-2021 | 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); 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 | Class II | 0169-2800-15, 0169-2800-90, 0169-2800-97 |
| D-0619-2021 | 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); 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 | Class I | 0169-2660-15, 0169-2660-90, 0169-2660-97, 0169-2550-13, 0169-2550-90, 0169-2550-97, 0169-2662-11, 0169-2662-90 |
| D-0620-2021 | TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90; JZFE233 exp 11/30/2021 | Class I | 0169-2660-15, 0169-2660-90, 0169-2660-97, 0169-2550-13, 0169-2550-90, 0169-2550-97, 0169-2662-11, 0169-2662-90 |
| D-0621-2021 | 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); 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 | Class I | 0169-2660-15, 0169-2660-90, 0169-2660-97, 0169-2550-13, 0169-2550-90, 0169-2550-97, 0169-2662-11, 0169-2662-90 |
| D-0622-2021 | ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit); I2419A (Kit); JS68K86 (Pen) exp 05/31/2021 | Class II | 0169-4060-13, 0169-4060-12, 0169-4060-90, 0169-4060-97, 0169-4060-98, 0169-4060-99 |
| D-0623-2021 | Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit); JP54291, exp 06/20/2021 | Class I | 0169-2911-15, 0169-2911-90, 0169-2911-97 |
What to do — step by step
Check Product Details
Identify if your Saxenda sample has the NDC codes 0169-2800-90 (Pen) or 0169-2800-97 (Kit), or batch codes like K1620A1 (Kit).
Questions people ask
Why was this sample recalled?
The samples were stored below 32°F, which could cause the product to become ineffective and damage the cartridge and pen-injector.
Is this sample safe to use?
No, the sample may be damaged due to improper storage, so it should not be used.
How can I tell if I have the recalled sample?
Look for Saxenda (liraglutide) injection samples with NDC 0169-2800-90 (Pen) or 0169-2800-97 (Kit), or batch codes like K1620A1 (Kit).
Contact Novo Nordisk
We’ve drafted a message you can send Novo Nordisk to request your refund or repair — edit it as you like.
Subject: Recall D-0618-2021 — Novo Nordisk Novo Nordisk Hello, I own a Novo Nordisk that is covered by recall D-0618-2021 from Novo Nordisk. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0618-2021 (March 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0618-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.