Rybelsus — Class II drug recall D-0536-2021
Terminated recall by Cardinal Health Inc., reported 2021-06-02, distributed in FL, GA, SC. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
| Recall number | D-0536-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2021-03-15 |
| Classified | 2021-05-24 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2024-06-17 |
| Distributed | FL, GA, SC |
| Quantity | 1,189 cartons |
| Reason classes | cgmp, temperature control |
| NDC | 00169-1704, 00169-1704-30, 00169-1709, 00169-1709-30, 00169-1715, 00169-1715-30, 00169-1715-90, 00169-4303, 00169-4303-01, 00169-4303-13, 00169-4303-30, 00169-4303-90, 00169-4303-93, 00169-4303-99, 00169-4307, 00169-4307-01, 00169-4307-13, 00169-4307-30, 00169-4314, 00169-4314-01, 00169-4314-13, 00169-4314-30, 00169-4804, 00169-4804-30, 00169-4809 and 4 more |
Product
Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0536-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.