drugs MODERATE Updated 2026-07-08

Boehringer Ingelheim Pharmaceuticals, Inc. recalls Synjardy XR Tablets (empagliflozin and metformin hydrochlori

See all recalls from Boehringer Ingelheim Pharmaceuticals, Inc. →

Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Affected States: OH
Lot/Code Info: Lot 3244413; Exp. 12/31/2028

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall