FDA-Drug2026-07-08Class IIPROCESSING DEFECT
Boehringer Ingelheim Synjardy XR recalled for manufacturing process deviation
What this means
Boehringer Ingelheim Pharmaceuticals is recalling one lot of Synjardy XR 12.5/1000 mg tablets due to manufacturing quality control issues. During production, an incorrect cleaning agent was used on equipment, and required testing of that equipment was not completed before the tablets were made.
- Check if your Synjardy XR matches lot 3244413 (expiration 12/31/2028).
- Contact your pharmacy or doctor if you have this lot — do not stop taking your medication without speaking to your healthcare provider first.
- Your pharmacist can verify the lot number on your bottle label.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
OH
Affected count
560 bottles
Manufactured in
900 Ridgebury Rd, N/A, Ridgefield, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0657-2026Want us to check the next one for you?
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