JARDIANCE — Class II drug recall D-0468-2023
Terminated recall by Boehringer Ingelheim Pharmaceuticals, Inc., reported 2023-03-29, distributed nationwide. Labeling: Label Mix-up
| Recall number | D-0468-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States |
| Recall initiated | 2023-03-09 |
| Classified | 2023-03-17 |
| Reported by FDA | 2023-03-29 |
| Terminated | 2023-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 69,375 bottles |
| Reason classes | labeling |
| NDC | 00597-0152, 00597-0152-07, 00597-0152-30, 00597-0152-37, 00597-0152-70, 00597-0152-90, 00597-0153, 00597-0153-07, 00597-0153-30, 00597-0153-37, 00597-0153-70, 00597-0153-90 |
| Expiration dates | 2025-06-20 |
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 for recall
Labeling: Label Mix-up
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-0468-2023. 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.