Boehringer Ingelheim Pharmaceuticals, Inc. recalls Synjardy XR Tablets
- Recalling company
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 12, 2026
- Reported
- Jul 8, 2026
- Distribution
- OH
- Status
- Ongoing
- Quantity
- 560 bottles
- Lot / codes
- Lot 3244413; Exp. 12/31/2028
- Company location
- Ridgefield, CT
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0657-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0657-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.