FDA Drug · 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, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA

Class II · Terminated

Labeling: Label Mix-up

Affected lots / codes — check yours against thisLot #: a) and b) E61835, exp. date JUN 2025

Recalling firm: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 69,375 bottles
Distribution: Product was distributed nationwide within the United States and PR
Recall initiated: March 9, 2023
Classified: March 17, 2023
Terminated: December 4, 2023
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0468-2023%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →