FDAFDA · Food and drugs·Recall number 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
Published March 29, 2023 · Recall initiated: March 9, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Mix-up
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- JARDIANCE
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Distributor
- Product was distributed nationwide within the United States and PR
- Lot
- Lot #: a) and b) E61835, exp. date JUN 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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