FDAFDA · Food and drugs·Recall number D-0657-2026
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
Published July 8, 2026 · Recall initiated: June 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Distributor
- OH
- Lot
- Lot 3244413; Exp. 12/31/2028
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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