CLASS II ONGOING Drug recall · Reported 7 May 2025 · FDA Enforcement Report
Wegovy (semaglutide) injection recalled by Cardinal Health
Cardinal Health is recalling Wegovy (semaglutide) injection, 4 mg/-Dose Prefilled Pens per, For Subcutaneous Use Only, distributed in North Carolina, South Carolina, Virginia. The recall was initiated on 9 Apr 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-0393-2025
- FDA event ID
- 96637
- Recalling firm
- Cardinal Health, Dublin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Apr 2025
- FDA classified
- 28 Apr 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Diabetes Medication
Timeline
| 9 Apr 2025 | Recall initiated by company | |
| 28 Apr 2025 | Classified by FDA | +19 days |
| 7 May 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
NC, SC, VA
Questions about this recall
Is Wegovy (semaglutide) injection, 4 mg/-Dose Prefilled Pens per, For Subcutaneous Use Only recalled?
Yes. Cardinal Health recalled Wegovy (semaglutide) injection, 4 mg/-Dose Prefilled Pens per, For Subcutaneous Use Only on 9 Apr 2025. The recall is Class II and its status is Ongoing. Recall number D-0393-2025.
Why was it 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.
Which lots are affected?
Lot PZFDE06, Exp 08/31/2025
Where was it sold?
NC, SC, VA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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