Official recall notice
FDA DrugClass IINotable
FDA Recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000
- Recall date
- 2026-07-08
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
Lot 3244413; Exp. 12/31/2028