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Class II · ModerateActive recall

Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot 3244413; Exp. 12/31/2028
Where it was soldOH
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
NDC00597-0300-45
Show the full FDA record
Full product labelSynjardy 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
Recalling firmBoehringer Ingelheim Pharmaceuticals, Inc.
DistributionOH
Quantity560 bottles
Recall initiated2026-06-12
Report date2026-07-08
Recall completed—
Recall numberD-0657-2026
ClassificationClass II
FDA statusOngoing
Origin on fileRidgefield CT United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.