⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Boehringer Ingelheim Pharmaceuticals, Inc.: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Dist

DrugsSource: FDA (drug) · Date: 2026-07-08

Read the official notice at FDA (drug) →

Share on XFacebookRedditEmail

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Boehringer Ingelheim Pharmaceuticals, Inc.
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 / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
OH
Recall initiated
2026-06-12
Code info
Lot 3244413; Exp. 12/31/2028
Product quantity
560 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Ridgefield
State
CT
Country
United States
Event id
99233
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.