FDA DrugsClass II
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release ...
Published: July 8, 2026Recall ID: D-0657-2026Category: drugsCountry: US
Reason for Recall / Hazard
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 & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Ridgefield |
| State | CT |
| Event id | 99233 |
| Address 1 | 900 Ridgebury Rd |
| Address 2 | N/A |
| Code info | Lot 3244413; Exp. 12/31/2028 |
| Postal code | 06877-1058 |
| Report date | 20260708 |
| Product type | Drugs |
| 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 |
| Recall initiation date | 20260612 |
| Initial firm notification | Letter |
| Center classification date | 20260630 |
Overview
- Recalling FirmBoehringer Ingelheim Pharmaceuticals, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionOH