Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets): recall status
Notice names this product. Boehringer Ingelheim Pharmaceuticals’s Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets) is named in FDA Class II recall D-0657-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: 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. Identifying details: Lot 3244413; Exp. 12/31/2028. Units affected: 560 bottles. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)
Company / brand
Boehringer Ingelheim Pharmaceuticals
Lot / serial / date codes
Lot 3244413; Exp. 12/31/2028
Distribution
OH
Agency product description and boundaries
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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.