Drug recall D-0657-2026

Class II Ongoing reported Jul 8, 2026

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 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.

Lots and codes

Lot 3244413; Exp. 12/31/2028

Recall details

Recalling firm
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Quantity
560 bottles
Distribution
OH
Type
Voluntary: Firm initiated
Recall initiated
June 12, 2026