FDA recall D-0468-2023

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

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

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