FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled July 8, 2026

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

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0657-2026
Brand
Boehringer Ingelheim Pharmaceuticals
Classification
Class II
Units affected
560 bottles
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

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

Affected products

Companies & origin

Recalling firm location
Ridgefield, CT, United States
Firm address
900 Ridgebury Rd, N/A, 06877-1058

Identifying details (verbatim from the notice)

Product codes / lots
Lot 3244413; Exp. 12/31/2028
Distribution
OH
Firm notified the public via
Letter
FDA event ID
99233
Recall initiated
June 12, 2026
FDA classified
June 30, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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