# FDA recall D-0468-2023

> **Boehringer Ingelheim Pharmaceuticals, Inc.** · Class II · drug recall initiated 2023-03-09.

## 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

## Distribution

Product was distributed nationwide within the United States and PR

## Key facts

- **Recall number:** D-0468-2023
- **Recalling firm:** Boehringer Ingelheim Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-03-09
- **Report date:** 2023-03-29
- **Termination date:** 2023-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ridgefield, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0468-2023

## Citation

> AI Analytics. FDA recall D-0468-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0468-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*