Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Is Empagliflozin recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Empagliflozin (8 total). Check the affected lots below.
Most common reason: Temperature excursion (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Empagliflozin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Empagliflozin recalls in 2026
1 initiated in 2026, 8 in total — newest first
Class II · Moderate risk
JARDIANCE (Empagliflozin)
Labeling: Label Mix-up
Class II · Moderate risk
Jardiance (empagliflozin tablets)
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Glyxambi (empagliflozin and linagliptin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
Cross Contamination With Other Products:
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