Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Saxagliptin recalled?

Yes — there is an active recall. 2 ongoing FDA recalls mention Saxagliptin (4 total). Check the affected lots below.

Most common reason: cGMP deviation (2 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Saxagliptin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Saxagliptin recalls on record

none so far in 2026; 4 on record, newest first
Class II · Moderate risk

Kombiglyze XR

Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.

Terminated Labeling / mix-up Bristol-myers Squibb Company D-019-2013
Class II · Moderate risk

Kombiglyze XR

Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.

Terminated Labeling / mix-up Bristol-myers Squibb Company D-018-2013