Empagliflozin/metformin tablets Recall: Synjardy XR 12.5/1000 mg
The recall involves Empagliflozin/metformin extended-release Synjardy XR tablets due to CGMP Deviations: an incorrect detergent was used and required swab sampling on a production hopper previously used for a different product was not performed. It is a moderate-severity recall affecting 560 bottles distributed in Ohio; Lot 3244413 with expiration 12/31/2028 is identified.
| Brand | Boehringer Ingelheim Pharmaceuticals, Inc. |
|---|---|
| Product | 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 |
| Reason | 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. |
| Severity | moderate |
| Units affected | 560 |
| Distribution | OH |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any Synjardy XR 12.5/1000 mg from Lot 3244413.
- Contact your pharmacist or healthcare provider to obtain a replacement or refund.
- Return the recalled product to the place of purchase or follow pharmacist guidance for disposal.
- If you experience any problems, contact your healthcare provider and report adverse events to the FDA MedWatch program.
How to identify the recalled item
| Lot / date codes | Lot 3244413; Exp. 12/31/2028 |
|---|---|
| Lot / date codes | Lot 3244413; Exp. 12/31/2028 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.