The Food and Drug Administration (FDA) has announced a recall of Levemir, Tresiba, Fiasp, Novolog, and Xultophy Product Samples (Novo Nordisk) due to improper storage temperature conditions.

These products are used to lower blood glucose levels in people with diabetes and are packaged in cartons with either a vial, pen-injector (FlexPen or FlexTouch), or a cartridge (PenFill). Novo Nordisk is voluntarily recalling 1468 product samples because they were stored at temperatures below storage requirements. This recall only impacts product samples and does not impact product that has been broadly distributed to pharmacies or mail-order services.

If product samples are exposed to temperatures below 32°F, it could cause a lack of efficacy and damage to the cartridge and pen injectors. If product from an improperly stored vial, cartridge, or pen injector is used, there is a risk that the patient might not receive the right amount of medicine as intended, which may lead to hyperglycemia or hypoglycemia resulting in adverse health consequences. Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall.

Food and Drug Administration (FDA). Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions. May 10, 2021. Available at: click here. Accessed May 11, 2021.