FDA Recall D-0393-2025

Cardinal Health Inc. · Dublin, OH

Class II Ongoing 400 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot PZFDE06, Exp 08/31/2025

Quantity: 48 Cartons

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.

Recall record

Recall number: D-0393-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: NC, SC, VA
Recall initiated: 2025-04-09
Classified by FDA Center: 2025-04-28
FDA published: 2025-05-07
Recalling firm: Cardinal Health Inc.
Firm location: Dublin, OH

Drug identification

Brand name(s): WEGOVY
Generic name(s): SEMAGLUTIDE
Manufacturer(s): Novo Nordisk
NDC(s): 0169-4404, 0169-4525, 0169-4505, 0169-4501, 0169-4517, 0169-4524, 0169-4415, 0169-4409, 0169-4425, 0169-4572
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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