FDA recall D-0657-2026

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 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.

Distribution

OH

Key facts

Status

Ongoing

Initiation date

2026-06-12

Report date

2026-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ridgefield, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0657-2026