FDA recall, , Moderate risk
Synjardy XR Tablets (Empagliflozin and Metformin Hydrochloride Extended-Release Tablets)
An incorrect detergent was used and required swab sampling was not performed on a production hopper.
Summary by Recall Canary from the FDA notice
What happened
Boehringer Ingelheim Pharmaceuticals, Inc., of Ridgefield, Connecticut, recalled Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only. The FDA reported that 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.
The recall began June 12, 2026, and was added to the FDA's Enforcement Report on June 30, 2026. The affected product is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, and was recalled in Ohio.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)
- NDC
- 00597-0300-45
- Lot code
- 3244413
Recall details
- Company began the recall
- Sold in
- Company
- Boehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, Connecticut
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99233
- Recall number
- D-0657-2026
- Quantity recalled
- 560 bottles
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
