FDA Drug recall D-0185-2024
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim…
- FDA Drug
- Class II
- terminated
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim… by Cardinal Healthcare, citing CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0185-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Healthcare |
| Distribution | US |
Product
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37
Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Identifiers
| ndc | 0597-0152-90 |
|---|---|
| ndc | 0597-0152-07 |
| ndc | 0597-0152-70 |
| ndc | 0597-0152-37 |
| ndc | 0597-0152-30 |
| ndc | 0597-0153-37 |
| ndc | 0597-0153-30 |
| ndc | 0597-0153-90 |
| ndc | 0597-0153-07 |
| ndc | 0597-0153-70 |
| code_info | Batch D41919 |
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-0185-2024%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.