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Drug recall · FDA · Published March 31, 2021

SUN PHARMACEUTICAL INDUSTRIES INC recalls Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only,

Sun Pharmaceutical recalls Riomet (metformin hydrochloride oral solution) 500mg/5mL Cherry Flavor bottles due to microbial contamination. This poses a risk of infection from non-sterile product. Consumers should check NDC 10631-206-02 and lot numbers listed.

🇺🇸 FDA recall #D-0334-2021DrugSun Pharmaceutical ›
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Contact the company & request your remedy

Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC2 Independence Way, N/A · Princeton, NJ 08540-6620
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sun Pharmaceutical is recalling Riomet metformin oral solution bottles that may contain harmful bacteria. Using these products could lead to infections, especially since they are prescription-only medications. Read more at govinfonow.com/recall/36223-sun-pharmaceutical-riomet-metformin-solution-recall-microbial-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36223-sun-pharmaceutical-riomet-metformin-solution-recall-microbial-contamination-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0334-2021

Cite this page

“Sun Pharmaceutical Riomet Metformin Solution Recall: Microbial Contamination Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36223-sun-pharmaceutical-riomet-metformin-solution-recall-microbial-contamination-risk. Based on FDA recall #D-0334-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0334-2021%22&limit=1).

Why it’s dangerous

The product may have been contaminated with bacteria during manufacturing, making it non-sterile. This could cause infections if the medication is taken as directed. Since it's a prescription drug, only patients with diabetes would use it.

Who’s affected

Prescription patients using Riomet metformin solution bottles with specific lot numbers and expiration dates. Those with diabetes who require this medication are most at risk.

How to tell if you have this one

Check for NDC 10631-206-02 and lot numbers: J190386A (exp. 3/2021), X190354A (exp. 3/2021), J190393A (exp. 5/2021), A200035A (exp. 6/2021), B200064A (exp. 8/2021), H200236A (exp. 1/2022).

  • Brand
    Sun Pharmaceutical
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for lot numbers on the bottle: J190386A, X190354A, J190393A, A200035A, B200064A, or H200236A.

  2. Contact Your Doctor

    If you have the recalled lot numbers, talk to your healthcare provider about alternative medications.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product may contain harmful bacteria and is not safe to use. Sun Pharmaceutical has recalled these specific bottles due to microbial contamination.

What should I do if I have the recalled product?

Check the lot number on the bottle. If it matches the recalled numbers, contact your doctor for alternative medication options.

How can I tell if I have the recalled product?

Look for NDC 10631-206-02 and lot numbers: J190386A (exp. 3/2021), X190354A (exp. 3/2021), J190393A (exp. 5/2021), A200035A (exp. 6/2021), B200064A (exp. 8/2021), or H200236A (exp. 1/2022).

Take action

Contact Sun Pharmaceutical

We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.

Subject: Recall D-0334-2021 — Sun Pharmaceutical Sun Pharmaceutical

Hello,

I own a Sun Pharmaceutical that is covered by recall D-0334-2021 from Sun Pharmaceutical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0334-2021 (March 31, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0334-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA