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

Recall Number: D-0657-2026

Firm: Boehringer Ingelheim Pharmaceuticals, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260708

Initiation Date: 20260612

Termination Date:

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.

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