Synjardy XR Tablets Recalled Due to CGMP Deviations
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Synjardy (empagliflozin and metformin hydrochloride) XR tablets, 12.5/1000 mg. The affected batch has been identified as Lot 3244413 (expires December 2028), affecting 560 bottles.
- The recall was initiated by Boehringer Ingelheim Pharmaceuticals, Inc due to Current Good Manufacturing Practice (CGMP) deviations, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
- Synjardy tablets are used to control blood sugar for patients with type 2 diabetes. They can also lower the risk of death from heart attack, stroke, or heart failure.
The FDA has issued a Class II recall for Synjardy (empagliflozin and metformin hydrochloride) XR tablets, 12.5/1000 mg, affecting 560 bottles. This product is being recalled by Boehringer Ingelheim Pharmaceuticals, Inc based in Ridgefield, Connecticut. The recall was initiated on June 12, 2026, and received a Class II classification on June 30, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
The recall was initiated due to CGMP deviations; the required swab sampling was not performed, and an incorrect detergent was used. This deficiency affects Lot 3244413, which will expire in December 2028. Boehringer Ingelheim Pharmaceuticals sent out a public notice via letter; no press release has been issued for this recall.
Synjardy tablets are used in combination with diet and exercise to control blood sugar levels for patients with type 2 diabetes. They are also used for to lower the risk of death from heart attack, stroke, or heart failure in patients with type 2 diabetes and heart disease. Pharmacists should identify and quarantine Lot 3244413, remove it from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. July 8, 2026. Accessed July 8, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221116
