Synjardy XR Tablets (empagliflozin and metformin hydrochloride exte…

Boehringer Ingelheim Pharmaceuticals, Inc. has recalled Synjardy XR Tablets (empagliflozin and metformin hydrochloride exte…, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on July 8, 2026 and was initiated on June 12, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Synjardy XR Tablets (empagliflozin and metformin hydrochloride exte…, with approximately 560 bottles affected. The company behind the recall is Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT. The FDA describes the product as: “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”

Why was Synjardy XR Tablets (empagliflozin and metformin hydrochloride exte… recalled?

According to the FDA, the stated reason for the recall is: “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.” In plain terms, this recall relates to a manufacturing quality issue (CGMP).

CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.

What should you do?

If you think you may have bought Synjardy XR Tablets (empagliflozin and metformin hydrochloride exte…, compare it against the product description and identifying codes (Lot 3244413; Exp. 12/31/2028) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Boehringer Ingelheim Pharmaceuticals, Inc. or your local health authority.

About this recall

This recall was distributed in CT. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.