FDA Drug recall D-0468-2023
JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Ma…
- FDA Drug
- Class II
- terminated
- Published 2023-03-29
On 2023-03-29 the FDA classified a Class II recall of JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Ma… by Boehringer Ingelheim Pharmaceuticals, citing labeling: Label Mix-up.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0468-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-03-09 |
| Published | 2023-03-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Boehringer Ingelheim Pharmaceuticals |
| Distribution | US |
Product
JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA
Reason
Labeling: Label Mix-up
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 | Lot #: a) and b) E61835, exp. date JUN 2025 |
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-0468-2023%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.