Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Ba
Summary
The FDA issued a Class II for Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manuf by Novo Nordisk Inc.. Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe.
Details
Source
Drug Recall
External ID
D-0245-2026
Action Date
2026-01-07
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027
Quantity Affected: N/A
Reason for Recall
Presence of Particulate Matter: Hair was found in a prefilled syringe
Distribution
Nationwide within the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-19
Company
Plainsboro, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Novo Nordisk Inc. has 6 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novo Nordisk Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novo Nordisk Inc. have FDA actions?
Novo Nordisk Inc. has 6 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0245-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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