SEMAGLUTIDE Recall D-0393-2025
Description: 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.
SEMAGLUTIDE Recall D-0393-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0393-2025 |
| Event ID | 96637 |
| Brand | WEGOVY |
| Generic Name | SEMAGLUTIDE |
| Manufacturer | SEMAGLUTIDE |
| Original Package? | 1 |
| Active Substance | SEMAGLUTIDE |
| Drug Route | SUBCUTANEOUS |
| Distribution | NC, SC, VA |
| Quantity | 48 Cartons |
| Recall Reason | 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. |
| Drug Classification | Class II |
| Drug Code Info | 20250507 |
| Product NDC | 0169-4501 0169-4525 0169-4505 |
| Product NUI | N0000178480 M0160181 N0000020058 |
| Pharma Class (EPC) | GLP-1 Receptor Agonist [EPC] |
| Pharma Class (CS) | Glucagon-Like Peptide 1 [CS] |
| Recall Initiation Date | 20250409 |
| Report Date | 20250507 |
| Classification Date | 20250428 |
| Address | 7000 Cardinal PlN/A Dublin, OH 43017-1091 United States |
| Recalling Firm | Cardinal Health Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 53AXN4NNHX |
| Drug Application Number | NDA215256 |
| Structured Product Labeling (SPL ID) | 6d001eae-d777-46c0-a89b-d55cae3faf7b |
| Structured Product Labeling (SPL Set ID) | ee06186f-2aa3-4990-a760-757579d8f77b |
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