Sun Pharmaceutical Riomet Oral Solution Recall: Microbial Contamination Risk
Sun Pharmaceutical recalls Cherry Flavored Riomet oral solution due to microbial contamination. This medication is for diabetes treatment and must be stopped if used.
Recall notice
Microbial Contamination of Non-Sterile Products
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling cherry-flavored Riomet oral solution (metformin) because it may contain harmful bacteria. This poses a risk of infection or illness if taken. Read more at govinfonow.com/recall/41687-sun-pharmaceutical-riomet-oral-solution-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41687-sun-pharmaceutical-riomet-oral-solution-recall-microbial-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0109-2018
Cite this page
“Sun Pharmaceutical Riomet Oral Solution Recall: Microbial Contamination Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41687-sun-pharmaceutical-riomet-oral-solution-recall-microbial-contamination-risk. Based on FDA recall #D-0109-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0109-2018%22&limit=1).
Why it’s dangerous
The medication may have been contaminated with bacteria during production, which could cause infections or illness if taken. This is a risk for people using the product as directed.
Who’s affected
People who have been prescribed this diabetes medication and are using the recalled cherry-flavored oral solution. Those with diabetes who take this specific formulation are most at risk.
How to tell if you have this one
Check for the cherry-flavored Riomet oral solution with 500 mg/5 mL concentration. The product comes in HDPE bottles labeled with NDC numbers 10631-206-01 (4 fl. oz.) or 10631-206-02 (16 fl. oz.).
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC numbers 10631-206-01 or 10631-206-02 on the bottle.
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 13 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.
Questions people ask
Is this medication safe to use?
The recall states there is a risk of microbial contamination, so it is not safe to use as is. You should stop using it and contact your doctor.
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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-0109-2018 (April 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0109-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.