D-0657-2026 Class II Ongoing
FDA drug recall D-0657-2026 was initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on Jun 12, 2026 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 560 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 8, 2026
- Initiation Date
- Jun 12, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 560 bottles
Product description
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 for recall
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.
Distribution pattern
OH
Code information
Lot 3244413; Exp. 12/31/2028
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0657-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026