← FDA ENFORCEMENT
D-0657-2026Class II

Boehringer Ingelheim Pharmaceuticals, Inc.

Recalling firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-07-08
Distribution
OH
Firm state
CT
Product quantity
560 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

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

Code / lot info

Lot 3244413; Exp. 12/31/2028

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.