Recall archive / FDA drug enforcement
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets pe... — FDA record D-0657-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 12, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Quantity
- 560 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0657-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot 3244413; Exp. 12/31/2028 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
OH
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 8, 2026
- Recall initiation date
- Jun 12, 2026
- Center classification date
- Jun 30, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.