Recalls / Class II
Class IID-0393-2025
Product
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.
- Brand name
- Wegovy
- Generic name
- Semaglutide
- Active ingredient
- Semaglutide
- Route
- Oral
- NDCs
- 0169-4404, 0169-4525, 0169-4505, 0169-4501, 0169-4517, 0169-4524, 0169-4415, 0169-4409, 0169-4425, 0169-4572
- FDA application
- NDA218316
- Affected lot / code info
- Lot PZFDE06, Exp 08/31/2025
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.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Novo Nordisk
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 48 Cartons
- Distribution pattern
- NC, SC, VA
Timeline
- Recall initiated
- 2025-04-09
- FDA classified
- 2025-04-28
- Posted by FDA
- 2025-05-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0393-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.