Synjardy XR Tablets
Boehringer Ingelheim is recalling Synjardy XR tablets due to manufacturing deviations involving improper cleaning and sampling of production equipment.
Contact your healthcare provider or pharmacist to discuss alternative treatment options. Do not stop taking your medication without consulting a medical professional.
Why it was recalled
Boehringer Ingelheim is recalling specific lots of Synjardy XR (empagliflozin and metformin hydrochloride) extended-release tablets due to current good manufacturing practice (CGMP) deviations. The recall was initiated because an incorrect detergent was used and required swab sampling was not performed on a production hopper previously used for a different product.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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 #
- D-0657-2026
Where it was sold
Distributed in Ohio.
Official source
Editorial summary by Recall Canary · last updated 2026-07-01 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification