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
Reported: March 29, 2023 Initiated: March 9, 2023 #D-0468-2023
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
Reason for Recall
Labeling: Label Mix-up
Details
- Recalling Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Units Affected
- 69,375 bottles
- Distribution
- Product was distributed nationwide within the United States and PR
- Location
- Ridgefield, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Boehringer Ingelheim Pharmaceuticals, Inc.. Units affected: 69,375 bottles.
Why was this product recalled? ▼
Labeling: Label Mix-up
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 29, 2023. Severity: Moderate. Recall number: D-0468-2023.
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