United States, January 8, 2026: Novo Nordisk, a pharmaceutical manufacturer in the United States, has voluntarily recalled four lots of its weight-loss medication Wegovy (semaglutide) after hair was discovered in prefilled pens during a quality inspection, according to a notice released by the FDA. The recall, initiated on December 19, 2025, affects both 0.5 mg and 1 mg doses distributed nationwide across the United States.
According to the FDA, Wegovy (semaglutide) injections are used to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.
The Food and Drug Administration (FDA) published two notices on December 31, 2025, confirming a Class II recall of the following lots:
Wegovy 0.5 mg (NDC 0169-4505-14): Lots RZFHD52 and RZFHW93, expiring October 31, 2026
Wegovy 1 mg (NDC 0169-4501-14): Lots RZFYK06 and RZFYA53, expiring March 31, 2027
The FDA classified the recall as Class II, indicating that use of the affected products “may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.”
In a statement issued on December 19, 2025, Novo Nordisk emphasized that the recall was initiated out of an abundance of caution. The company stated that “any potential medical risk is considered unlikely or minor.”
Novo Nordisk explained that the two pen injectors containing particulate matter were identified during inspection and were never sent to the retail level or to patients. The company added, “There are no confirmed reports of this issue in any Wegovy pens already on the market, and no adverse effects related to products from these lots have been reported to date.”
The pharmaceutical giant reassured patients and healthcare providers, stating, “Patient safety is our top priority, and we are committed to ensuring that all of our products are of the highest quality.”
Novo Nordisk has advised that “no action from patients is needed or recommended at this time.” The company emphasized that any potential medical risk would most likely be minor.
The recall is being conducted at the retail level, with Novo Nordisk sending letters to pharmacies and other consignees. The company stated that it “will work closely with the FDA and other stakeholders to ensure an appropriate process is in place so that the recall is handled safely and promptly.”
According to Novo Nordisk, there is ample supply of Wegovy in the U.S. market, and no supply disruptions are expected as a result of this voluntary recall.
Patients who experience adverse reactions to Wegovy should contact their healthcare professional for guidance. Healthcare professionals and customers can report any adverse events or concerns to Novo Nordisk Customer Service at 1-800-727-6500.
The recall remains ongoing, with the FDA monitoring the situation closely. No termination date has been announced.
(Rh/VK/MSM)
