FDA Drug · D-0657-2026

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

Class II · Ongoing

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.

Affected lots / codes — check yours against thisLot 3244413; Exp. 12/31/2028

Recalling firm: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 560 bottles
Distribution: OH
Recall initiated: June 12, 2026
Classified: June 30, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0657-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

See every recall for this brand: Is Boehringer Ingelheim Pharmaceuticals, Inc. recalled? →

Check this brand across all 8 databases →