Recalls / Class II
Class IID-0245-2026
Product
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
- 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 #: RZFYK06, RZFYA53; Exp Date 3/31/2027
Why it was recalled
Presence of Particulate Matter: Hair was found in a prefilled syringe
Recalling firm
- Firm
- Novo Nordisk Inc.
- Manufacturer
- Novo Nordisk
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 800 Scudders Mill Rd, N/A, Plainsboro, New Jersey 08536-1606
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide within the United States.
Timeline
- Recall initiated
- 2025-12-19
- FDA classified
- 2025-12-31
- Posted by FDA
- 2026-01-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0245-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.