Synjardy Tablets Recall: Cross Contamination Risk
Boehringer Ingelheim recalls Synjardy (empagliflozin and metformin) tablets due to cross contamination risk. This prescription medication (5mg/1000mg) is in 180-count bottles with specific lot numbers.
Lower-risk recall
Cross Contamination With Other Products:
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What happened, in plain English
Boehringer Ingelheim is recalling Synjardy tablets (5 mg/1000 mg) because they may have been contaminated with other products during manufacturing. This recall affects prescription-only medication bottles sold between 2018 and 2019. Read more at govinfonow.com/recall/39660-synjardy-tablets-recall-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39660-synjardy-tablets-recall-cross-contamination-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1217-2018
Cite this page
“Synjardy Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39660-synjardy-tablets-recall-cross-contamination-risk. Based on FDA recall #D-1217-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1217-2018%22&limit=1).
Why it’s dangerous
Cross contamination during manufacturing could introduce other products into the Synjardy tablets. This might cause unintended medication interactions or side effects, though the risk is not severe.
Who’s affected
Prescription patients who have the specific 180-count bottle of Synjardy tablets with lot number 603968 (expired 4/2019) are affected. People using this medication for diabetes management are most at risk.
How to tell if you have this one
Check for the 180-count bottle labeled Synjardy (5 mg/1000 mg) with lot number 603968, manufactured in Germany, and expired by April 2019.
- Brand
Boehringer Ingelheim- Category
Drug
What to do — step by step
Check Your Medication
Look for the specific lot number 603968 on the bottle label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1217-2018 (September 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1217-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.