Answer
Jan 15, 2026 - 11:02 AM
Kombiglyze XR was discontinued in the United States because of an AstraZeneca business decision—not because the FDA determined it was unsafe or ineffective. The manufacturer permanently stopped marketing the brand in 2023 but did not publicly provide a more specific commercial explanation. It was not an FDA recall.
Kombiglyze XR did carry important safety warnings. Its saxagliptin component has been associated with an increased risk of heart failure, particularly in people with existing heart or kidney problems, while metformin carries a risk of lactic acidosis in susceptible patients. However, these warnings were not reported as the reason for the product’s discontinuation.
The medication itself has not disappeared entirely: FDA-approved generic saxagliptin/metformin extended-release products are available from manufacturers such as Mylan and Dr. Reddy’s.
Availability also depends on the country. In Canada, a related product is marketed as Komboglyze, and AstraZeneca Canada currently maintains a product monograph for it.
