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TemporaryFDAOngoing

Can cause harm that is usually temporary. Speak to your pharmacist or doctor — do not stop a prescribed medicine on your own.

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

Check the label for

Lot 3244413; Exp. 12/31/2028
Why
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.
Distributed
OH
Company
Boehringer Ingelheim Pharmaceuticals, Inc.
Announced
This is the date the recall was announced. A company may have started it weeks earlier.
Recall began

Already ate or took it and feel unwell? Call Poison Control — 1-800-222-1222

Source: FDA record D-0657-2026 · retrieved 30 June 2026

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