Reported Jul 8, 2026 · Ongoing
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per…
Boehringer Ingelheim Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Pharmaceuticals, Inc. · 900 Ridgebury Rd · Ridgefield, CT · 06877-1058
Is this the product you have?
- Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only
- Distributed byBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
- NDC00597-0300-45
- Lot codes and dates
Lot 3244413Exp. 12/31/2028
- Amount recalled
- 560 bottles
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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