The Recall Desk
ModerateFDA (Drugs)·D-0618-2021·Announced 2021-04-21

Novo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse

Novo Nordisk is recalling Saxenda (liraglutide) injection samples that were stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential lack of efficacy and physical damage to the device due to temperature abuse, which fits the criteria for moderate severity without reported injuries.

Plain-English summary

Novo Nordisk Inc. is recalling Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. The recall is due to temperature abuse, where product samples were stored at temperatures below 32°F, which is not in accordance with storage requirements.

This temperature deviation could cause a lack of efficacy and damage to the cartridge and pen-injectors. The affected products are identified by specific lot codes and expiration dates, including K1620A1 (Kit) and KZFH714 (Pen) exp 05/31/2022, B2020A (Kit) and JZFF482 (Pen) exp 11/30/2021, I2320A (Kit) and KZFH714 (Pen) exp 05/31/2022, H1020A (Kit) and KZFH714 (Pen) exp 05/31/2022, and J0520A (Kit) and KZFH714 (Pen) exp 05/31/2022.

The recall is distributed nationwide in the USA. Consumers and healthcare providers should check their Saxenda samples against the listed lot codes and expiration dates. If the product matches the recalled items, it should not be used.

The recalled product

Product
SAXENDA (LIRAGLUTIDE)
Brand
SAXENDA
Manufacturer
Novo Nordisk Inc
Category
Drug — Prescription Injection
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • K1620A1 (Kit)
  • KZFH714 (Pen) exp 05/31/2022
  • B2020A (Kit)
  • JZFF482 (Pen) exp 11/30/2021
  • I2320A (Kit)
  • H1020A (Kit)
  • J0520A(Kit)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Novo Nordisk Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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