Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per B
Summary
The FDA issued a Class II for Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release by 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.
Details
Source
Drug Recall
External ID
D-0657-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot 3244413; Exp. 12/31/2028
Quantity Affected: 560 bottles
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.
Distribution
OH
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-12
Company
Ridgefield, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 81 drug-related FDA actions this month.
Boehringer Ingelheim Pharmaceuticals, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boehringer Ingelheim Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boehringer Ingelheim Pharmaceuticals, Inc. have FDA actions?
Boehringer Ingelheim Pharmaceuticals, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0657-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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