FDA Issues Class II Recall for Wegovy

The US Food and Drug Administration (FDA) has issued a Class II recall for Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, following a temperature excursion incident during distribution. The affected product, Lot PZFDE06, with an expiration date of August 31, 2025, includes 48 cartons that were inadvertently removed from refrigerated storage for an extended period and improperly released. The recall was initiated on April 9, 2025, after Cardinal Health identified the storage deviation at one of its distribution centers.

The recall was voluntarily initiated by Cardinal Health Inc., based in Dublin, Ohio, and involves a product manufactured by Novo Nordisk A/S in Denmark and distributed by Novo Nordisk Inc. in Plainsboro, New Jersey. The FDA officially classified the recall as Class II on April 28, 2025, indicating that the affected product's use may cause temporary or medically reversible adverse health consequences. Still, the probability of serious injury is remote. Distribution of the affected product was limited to North Carolina, South Carolina, and Virginia.

Wegovy (semaglutide) is a GLP-1 receptor agonist indicated for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity, such as hypertension or type 2 diabetes. Proper refrigerated storage is essential to maintaining the drug's potency and stability.