Novo Nordisk Inc initiated a Class II recall of Saxenda (liraglutide) on March 22, 2021. The recall affected Saxenda Injection, 18 mg/3 mL (6 mg/mL) prefilled pen samples, not for resale, NDC 0169-2800-90 and NDC 0169-2800-97.
The reason given was temperature abuse. Product samples were stored at temperatures below 32 degrees Fahrenheit, which does not meet required storage conditions. According to the recall record, this could cause a lack of efficacy and damage to the cartridge and pen injectors.
The recall was classified as Class II by the FDA. The recall status is listed as terminated. The recalling firm is Novo Nordisk Inc, based in Plainsboro, NJ, with manufacturing by Novo Nordisk A/S in Bagsvaerd, Denmark.
This recall record reflects the reason and classification as reported and does not by itself establish that any patient was harmed. Saxenda remains an approved product containing liraglutide.
For more background on this compound, readers can consult the liraglutide overview.