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.
Recall at a glance
- Quantity recalled
- 560 bottles
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/
- Lot code
- 3244413
- Strength
- 1000 mg
- NDC / UPC
- NDC 00597-0300-45
Where it was sold
Distributed in Ohio.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Manufacturing Deviation recalls
Editorial summary by Recall Canary · summary updated 2026-07-01 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification