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Drug recall · FDA · Published September 17, 2018

Medline Industries Inc recalls SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number

Medline recalls SparkleFresh Fluoride Toothpaste due to microbial contamination in non-sterile product. Affected tubes include 17g, 24g, and 42.5g sizes with specific lot numbers and expiration dates.

🇺🇸 FDA recall #D-0247-2019DrugMedline ›
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Contact the company & request your remedy

Recalling firmMedline Industries IncThree Lakes Drive · Northfield, IL 60093
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

Medline is recalling SparkleFresh Fluoride Toothpaste because it may contain harmful microorganisms. Using this toothpaste could pose a health risk, especially for people with weakened immune systems. Read more at govinfonow.com/recall/39566-medline-sparklefresh-fluoride-toothpaste-recall-microbial-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39566-medline-sparklefresh-fluoride-toothpaste-recall-microbial-contamination-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0247-2019

Cite this page

“Medline SparkleFresh Fluoride Toothpaste Recall: Microbial Contamination Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39566-medline-sparklefresh-fluoride-toothpaste-recall-microbial-contamination-risk. Based on FDA recall #D-0247-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0247-2019%22&limit=1).

Why it’s dangerous

The toothpaste may have been contaminated with microorganisms during manufacturing. This contamination could lead to infections, particularly for individuals with weakened immune systems who are more susceptible to infections.

Who’s affected

People who own or use the recalled SparkleFresh Fluoride Toothpaste are affected. Those with compromised immune systems may be at higher risk due to potential microbial contamination.

How to tell if you have this one

Check for the product name 'SparkleFresh Fluoride Toothpaste' with sizes 17g, 24g, or 42.5g. Look for lot numbers 102920C, 111220C, 111620D, 111420D, or 111720C on the tube.

  • Brand
    Medline
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product size and lot number to confirm if it's affected.

  2. Discard Affected Product

    If the product matches the recalled details, safely dispose of it to avoid potential health risks.

✎ GovInfoNow

Questions people ask

Is this toothpaste safe to use?

The recall indicates a potential microbial contamination risk, so it's recommended to discard affected products until a safe alternative is found.

What should I do if I have the recalled toothpaste?

Check the product details to confirm if it's affected. If it is, safely discard it to avoid potential health risks.

Are there any specific health risks for certain groups?

People with weakened immune systems may be at higher risk due to potential microbial contamination.

Take action

Contact Medline

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

Subject: Recall D-0247-2019 — Medline Medline

Hello,

I own a Medline that is covered by recall D-0247-2019 from Medline.

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-0247-2019 (September 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0247-2019 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.
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