FDA Drug recall D-0536-2021
Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0536-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 0169-1715-30 |
|---|---|
| ndc | 0169-1715-90 |
| ndc | 0169-1704-30 |
| ndc | 0169-1709-30 |
| ndc | 0169-4303-01 |
| ndc | 0169-4303-13 |
| ndc | 0169-4303-90 |
| ndc | 0169-4303-93 |
| ndc | 0169-4303-30 |
| ndc | 0169-4303-99 |
| ndc | 0169-4307-01 |
| ndc | 0169-4307-13 |
| ndc | 0169-4307-30 |
| ndc | 0169-4314-01 |
| ndc | 0169-4314-13 |
| ndc | 0169-4314-30 |
| ndc | 0169-4815-30 |
| ndc | 0169-4815-90 |
| ndc | 0169-4804-30 |
| ndc | 0169-4809-30 |
| code_info | K082347 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0536-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.