Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets) recall
Boehringer Ingelheim Pharmaceuticals, Inc. recalled Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets) on July 8, 2026 because of 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. It was sold in OH.
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.
What's recalled
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
Quantity: 560 bottles
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- OH
- Status
- Ongoing
- Recall number
- D-0657-2026
- Source
- U.S. Food and Drug Administration
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