Wegovy (semaglutide) injection recall
FDA recall D-0393-2025 · initiated Apr 9, 2025
Cardinal Health Inc. recalled Wegovy (semaglutide) injection in Apr 2025 — an FDA Class II recall (D-0393-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 48 Cartons
Details
- 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.
- Recalling company
- Cardinal Health Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- NC, SC, VA
- Initiated
- Apr 9, 2025
- FDA report date
- May 7, 2025
Frequently asked
- Was Wegovy (semaglutide) injection recalled?
- Cardinal Health Inc. recalled Wegovy (semaglutide) injection in Apr 2025 — an FDA Class II recall (D-0393-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Wegovy (semaglutide) injection recalled?
- Per the FDA enforcement record, the reason for recall D-0393-2025 was: 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.
- Is a recalled Wegovy (semaglutide) injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Wegovy (semaglutide) injection are affected?
- Distributed: NC, SC, VA. The recall covers these lots — Lot PZFDE06, Exp 08/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0393-2025.