Drug Recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridg
Boehringer Ingelheim Pharmaceuticals, Inc. · June 12, 2026
Reason for Recall
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
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
Distribution
OH
States Affected
OH
Quantity Affected
560 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0657-2026
Status: ongoing
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