Quick Facts at a Glance
- Recall Date
- June 12, 2026
- Hazard Level
- HIGH
- Brand
- Boehringer Ingelheim Pharmaceuticals
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boehringer Ingelheim Pharmaceuticals
- Model numbers
- Lot 3244413, Exp. 12/31/2028
- Where affected
- OH
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 12, 2026
Reported by FDA DRUG
July 8, 2026
RecallRadar source check
July 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Boehringer Ingelheim Pharmaceuticals, Inc. or your healthcare provider for guidance. Notification method: Letter
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Full 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. 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.. Classification: Class II. Quantity: 560 bottles. Distribution: OH
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Safety Guide
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