Boehringer Ingelheim Pharmaceuticals, Inc.: Synjardy Xr Tablets (empagliflozin And Metformin Hydrochloride Extended-release Tablets), 12.5/1000 Mg, 60 Tablets Per Bottle

Synjardy XR Recall Summary Boehringer Ingelheim is recalling Synjardy XR Tablets (12.5/1000 mg) distributed in Ohio due to manufacturing process deviations. An incorrect detergent was used to clean production equipment, and required cleaning verification tests were not performed on a hopper previously used for a different product. This is a Class II recall, meaning the product could cause temporary or reversible health problems.

Recalling firm

Boehringer Ingelheim Pharmaceuticals, Inc.

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

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-12

Status

Ongoing

Areas affected

OH

Distribution

OH

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/9589e85a-740d-4fc8-ada1-165dcf888125