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 I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: a) and b) E61835, exp. date JUN 2025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Boehringer Ingelheim Pharmaceuticals, Inc.
Reason for Recall:
Labeling: Label Mix-up
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

Lot #: a) and b) E61835, exp. date JUN 2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0468-2023

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