Wegovy prefilled pens recalled after hair was found in a syringe
Novo Nordisk is recalling Wegovy (semaglutide) Injection, 1 mg/0.5 mL prefilled pens, over the presence of particulate matter after hair was found in a prefilled syringe.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: particulate matter found inside an injectable product is a stated contaminant, and no injuries are reported.
Plain-English summary
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, supplied as 4 single-dose prefilled pens, manufactured by Novo Nordisk A/S of Bagsvaerd, Denmark, under NDC 0169-4501-14, is being recalled.
The reason given in the enforcement record is the presence of particulate matter: hair was found in a prefilled syringe.
The recall covers lots RZFYK06 and RZFYA53, both with an expiry date of 3/31/2027. The record does not state a quantity. Distribution was nationwide within the United States. The FDA has classified the action as Class II.
Patients should not stop using a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific pen is affected and arrange a replacement.
The recalled product
- Product
- Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
- Manufacturer
- Novo Nordisk Inc.
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: RZFYK06
- RZFYA53
- Exp Date 3/31/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Novo Nordisk Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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