Jardiance Tablet, Film Coated
FDA Recall NDC 0597-0152
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Jardiance (NDC 0597-0152). A significant event, classified as Class II, was initiated on Mar 09, 2023 by Boehringer Ingelheim Pharmaceuticals, Inc.. The reported reason for this action was: "Labeling: Label Mix-up"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Label Mix-up
Mar 09, 2023
Mar 29, 2023
69,375 bottles
Recall Profile & Regulatory Data
Event ID
91879
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide within the United States and PR
Termination Date
Dec 04, 2023
Product Description
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
Batch or Lot Expiration Information
Lot# : a) and b) E61835, exp. date JUN 2025
Affected Packages Involved in this Recall
0597-0152-90Product
0597-0152-07Product
0597-0152-70Product
0597-0152-37Product
0597-0152-30Product
0597-0153-37Product
0597-0153-30Product
0597-0153-90Product
0597-0153-07Product
0597-0153-70Product
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
1 unit
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37
Batch or Lot Expiration Information
Batch# Batch D41919
Affected Packages Involved in this Recall
0597-0152-90Product
0597-0152-07Product
0597-0152-70Product
0597-0152-37Product
0597-0152-30Product
0597-0153-37Product
0597-0153-30Product
0597-0153-90Product
0597-0153-07Product
0597-0153-70Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
