Why it was recalled
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Product description
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
Lot numbers, UPCs & expiration codes
Lot 3244413; Exp. 12/31/2028
Where it was sold
OH
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-0657-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 12, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- 560 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0657-2026, exactly as published.
Show all FDA fields
- City
- Ridgefield
- State
- CT
- Status
- Ongoing
- Country
- United States
- Event ID
- 99233
- Address
- 900 Ridgebury Rd
- Code information
- Lot 3244413; Exp. 12/31/2028
- Postal code
- 06877-1058
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0657-2026
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product quantity
- 560 bottles
- Reason for recall
- CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
- Distribution pattern
- OH
- Recall initiation date
- Jun 12, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 30, 2026