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Drug FDA Class II Ongoing Quality

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.

Cardinal Health Inc. Published May 7, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Cardinal Health Inc. or your place of purchase with questions, and see the source record below for full details.
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.

Affected products (1)

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.

WEGOVY · 48 Cartons

NDC: 0169-1605, 0169-4525, 0169-4505, 0169-4501, 0169-4517, 0169-4524, 0169-4572, 0169-1602, 0169-1610, 0169-1617, 0169-1624, 0169-4404, 0169-4415, 0169-4409, 0169-4425, 0169-4525-01, 0169-4525-14, 0169-4525-90, 0169-4525-94, 0169-4505-01, 0169-4505-14, 0169-4501-01, 0169-4501-14, 0169-4517-01, 0169-4517-14, 0169-4524-01, 0169-4524-14, 0169-4572-01, 0169-4572-14, 0169-1602-01, 0169-1602-14, 0169-1602-90, 0169-1602-94, 0169-1605-01, 0169-1605-14, 0169-1610-01, 0169-1610-14, 0169-1617-01, 0169-1617-14, 0169-1624-01, 0169-1624-14, 0169-4404-31, 0169-4415-31, 0169-4415-92, 0169-4409-31, 0169-4425-31
Lot codes: PZFDE06
Code info: Lot PZFDE06, Exp 08/31/2025

Affected areas

North CarolinaSouth CarolinaVirginia

Timeline

  1. Initiated
    Apr 9, 2025
  2. Published
    May 7, 2025
Recall number
D-0393-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.