Why it was recalled
Labeling: Label Mix-up
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
Lot numbers, UPCs & expiration codes
Lot #: a) and b) E61835, exp. date JUN 2025
Where it was sold
Product was distributed nationwide within the United States and PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0468-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 9, 2023
- FDA report date
- Mar 29, 2023
- Quantity
- 69,375 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0468-2023, exactly as published.
Show all FDA fields
- City
- Ridgefield
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 91879
- Address
- 900 Ridgebury Rd
- Code information
- Lot #: a) and b) E61835, exp. date JUN 2025
- Postal code
- 06877-1058
- Report date
- Mar 29, 2023
- Product type
- Drugs
- Recall number
- D-0468-2023
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product quantity
- 69,375 bottles
- Termination date
- Dec 4, 2023
- Reason for recall
- Labeling: Label Mix-up
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed nationwide within the United States and PR
- Recall initiation date
- Mar 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 17, 2023