OVERLOOKED

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Class IIOngoing

Boehringer Ingelheim Pharmaceuticals, Inc. recalls Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)

Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Boehringer Ingelheim Pharmaceuticals, Inc.
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
OH
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99233…

Products

  1. 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

    Codes/lots: Lot 3244413; Exp. 12/31/2028Quantity: 560 bottlesRecall no. D-0657-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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