Recalls / Class II
Class IID-0468-2023
Product
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
- Brand name
- Jardiance
- Generic name
- Empagliflozin
- Active ingredient
- Empagliflozin
- Route
- Oral
- NDCs
- 0597-0152, 0597-0153
- FDA application
- NDA204629
- Affected lot / code info
- Lot #: a) and b) E61835, exp. date JUN 2025
Why it was recalled
Labeling: Label Mix-up
Recalling firm
- Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 900 Ridgebury Rd, N/A, Ridgefield, Connecticut 06877-1058
Distribution
- Quantity
- 69,375 bottles
- Distribution pattern
- Product was distributed nationwide within the United States and PR
Timeline
- Recall initiated
- 2023-03-09
- FDA classified
- 2023-03-17
- Posted by FDA
- 2023-03-29
- Terminated
- 2023-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0468-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.