Class II · Moderate risk
SEMAGLUTIDE 20mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Wegovy (semaglutide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.
Affected NDC
0169-4524-14
Compare with the code on your package — it is the most precise check available.
Drug: Semaglutide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Wegovy semaglutide NDC 00169-4524 |
2.4 mg/.75mL | Injection, Solution Subcutaneous |
Novo Nordisk Pharmaceutical Industries, LP | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 0169-4524-14
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0393-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Semaglutide recalls
See all
Class II · Moderate risk
SEMAGLUTIDE 10mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 7.5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 2.5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Other recalls by Cardinal Health Inc.
All 2025 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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