The Recall Desk
ModerateFDA (Drugs)·D-0617-2021·Announced 2021-04-21

Novo Nordisk Recalls OZEMPIC Injection Pens Due to Temperature Abuse

Novo Nordisk is recalling OZEMPIC sample pens stored below 32°F, which 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 improper storage, without reported injuries or illnesses.

Plain-English summary

Novo Nordisk Inc is recalling specific samples of OZEMPIC (semaglutide) injection, 2 mg/1.5 mL prefilled pens. The recall involves products that were stored at temperatures below 32°F, which does not meet the required storage conditions.

The temperature abuse 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 KP50867, KP53021, and others listed in the recall notice.

These samples were distributed nationwide in the USA. Consumers and healthcare providers should check their OZEMPIC sample pens against the provided lot codes and expiration dates. If a product is affected, it should not be used, and individuals should contact Novo Nordisk or their healthcare provider for further instructions.

The recalled product

Product
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)
Manufacturer
Novo Nordisk Inc
Category
Drug — Injectable Medication
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 (20)

  • 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
  • KP52270
  • exp 01/31/2023
  • KP52722

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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