D-0657-2026 Class II Ongoing
FDA drug recall D-0657-2026 was initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on June 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
- July 8, 2026
- Initiation Date
- June 12, 2026
- Termination Date
- N/A
- 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