CLASS II ONGOING Drug recall · Reported 7 Jan 2026 · FDA Enforcement Report
Wegovy (semaglutide) Injection, 1 mg/-Dose Prefilled Pens recalled
Novo Nordisk is recalling Wegovy (semaglutide) Injection, 1 mg/-Dose Prefilled Pens, distributed nationwide in the US. The recall was initiated on 19 Dec 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0245-2026
- FDA event ID
- 98100
- Recalling firm
- Novo Nordisk, Plainsboro, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Dec 2025
- FDA classified
- 31 Dec 2025
- Reported
- 7 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Diabetes Medication
Timeline
| 19 Dec 2025 | Recall initiated by company | |
| 31 Dec 2025 | Classified by FDA | +12 days |
| 7 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Hair was found in a prefilled syringe
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Hair was found in a prefilled syringe
Which lots are affected?
Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027
Where was it sold?
Nationwide within the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98100| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Wegovy (semaglutide) Injection, 0.5 mg/-Dose Prefilled Pens recalled | Novo Nordisk | Particulate Matter | Nationwide |
More recalls from Novo Nordisk
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Wegovy (semaglutide) Injection, 0.5 mg/-Dose Prefilled Pens recalled | Novo Nordisk | Particulate Matter | Nationwide |
| Drug | CLASS I | Tresiba FlexTouch (insulin degludec injection)/mL recalledTresiba | Novo Nordisk | Temperature Abuse | Nationwide |
| Drug | CLASS I | NovoLog (Insulin aspart) Injection/mL (U-100) recalled by Novo NordiskInsulin Diluting Medium For Novolog | Novo Nordisk | Temperature Abuse | Nationwide |
| Drug | CLASS I | Tresiba FlexTouch (insulin degludec injection)/mL recalledTresiba | Novo Nordisk | Temperature Abuse | Nationwide |
| Drug | CLASS I | Fiasp FlexTouch (insulin aspart injection)/mL recalled by Novo NordiskFiasp | Novo Nordisk | Temperature Abuse | Nationwide |
Other Wegovy (semaglutide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Wegovy (semaglutide) Injection, 0.5 mg/-Dose Prefilled Pens recalled | Novo Nordisk | Particulate Matter | Nationwide |
| Drug | CLASS II | Wegovy (semaglutide) injection recalled by Cardinal Health | Cardinal Health | Temperature Abuse | NC, SC, VA |