FDA Issues Class II Recall for Wegovy (Semaglutide) Prefilled Pens Due to Contamination

The US Food and Drug Administration (FDA) has issued a Class II recall for 2 presentations of Wegovy (semaglutide) Injection—0.5 mg/0.5 mL and 1 mg/0.5 mL—following the detection of particulate matter identified as hair inside prefilled syringes. The affected products were manufactured by Novo Nordisk A/S in Denmark and distributed by Novo Nordisk Inc., based in Plainsboro, NJ. The recall involves the following lots:

• Lot RZFHD52 and RZFHW93, Exp. 10/31/2026 (0.5 mg)
• Lot RZFYK06 and RZFYA53, Exp. 3/31/2027 (1 mg)

The recall was initiated on December 19, 2025, and affects nationwide distribution in the United States.

The FDA classified the recall as Class II on December 31, 2025, indicating that use of the affected product may cause temporary or medically reversible adverse health consequences, with a low probability of serious adverse effects. Although no injuries or adverse events have been publicly reported, the presence of a foreign contaminant in a sterile injectable product represents a serious manufacturing quality issue. Novo Nordisk initiated the recall voluntarily and has been notifying consignees via formal letters. 

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 type 2 diabetes, hypertension, or dyslipidemia. Given its injectable, subcutaneous administration, any contamination—especially involving foreign materials like hair—poses risks of local injection site reactions, patient distress, and possible infections. Pharmacists should identify and quarantine the affected lot numbers, educate patients on how to inspect their pens prior to use, and facilitate replacements or communication with prescribers as needed. 

Reference
FDA. Enforcement Report. January 7, 2026. Accessed January 7, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm