Lower riskDrug recall · FDA · Published June 12, 2026
Synjardy XR Tablets Recall: Incorrect Detergent Used in Manufacturing
Boehringer Ingelheim recalls Synjardy XR tablets due to potential contamination from incorrect detergent use during production. Affected lots may have unsafe levels of impurities.
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.
“Synjardy XR Tablets Recall: Incorrect Detergent Used in Manufacturing.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31197-synjardy-xr-tablets-recall-incorrect-detergent-used-in-manufacturing. Based on FDA recall #D-0657-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0657-2026%22&limit=1).
Boehringer Ingelheim Pharmaceuticals, Inc. voluntarily recalled Synjardy XR Tablets due to CGMP deviations involving an incorrect detergent and missed swab sampling, according to the FDA on June 12, 2026.
How to tell if you have it
Brand: Boehringer Ingelheim
Product: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)
Strength: 12.5/1000 mg
Packaging: 60 Tablets per Bottle
NDC: 00597-0300-45
Lot Code: 3244413
Expiration Date: 12/31/2028
Quantity: 560 bottles
Distribution: OH
The hazard
The recall cites CGMP deviations where an incorrect detergent was used and required swab sampling was not performed on a production hopper previously used for a different product.
Context
GovInfoNow's records show Boehringer Ingelheim Pharmaceuticals, Inc. has had 9 other recalls since October 6, 2016. Previous brand recalls include JARDIANCE 25mg Tablets on March 9, 2023, and Micardis Tablets 80mg on May 4, 2021. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets (August 5, 2026), Unichem Bisoprolol/Hydrochlorothiazide Tablets (January 21, 2026), and Macleods Olanzapine Tablets 5mg (August 27, 2026).
How to tell if you have this one
Check the product label for the lot number 3244413 and expiration date 12/31/2028. The tablets are prescription-only and come in 60-count bottles with the NDC code 00597-0300-45.
Brand
Boehringer Ingelheim
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the lot number 3244413 and expiration date 12/31/2028 on the tablet packaging.
Where it went and when
Where it was distributed
Distributed in Ohio.
Listed by the agency
Not listed
FDA distribution: “OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio.
Recall timeline
FDA published this recall 26 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0657-2026 (June 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0657-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.