Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported November 14, 2018
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA
Microbial Contamination of Non-Sterile Product
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Medline Industries Inc recalled SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 533… - a moderate-severity action.
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 533… was recalled by Medline Industries Inc in November 14, 2018. Reason: Microbial Contamination of Non-Sterile Product. Check the official notice for the remedy. Verify recall #D-0247-2019 with the FDA Drug before acting.
The recall
Medline Industries Inc issued this moderate-severity FDA Drug recall-Microbial Contamination of Non-Sterile Product.
- Moderate
- severity level
- Class II
- classification
- November 14, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0247-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0247-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on September 17, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Medline Industries Inc is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 994,756 tubes.
The documented reason for this recall is: Microbial Contamination of Non-Sterile Product Distribution data in the federal record shows the product reached: Nationwide USA and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Cosmetics & Personal Care recalls over time
Where this recall sits in its category - 1,360 cosmetics & personal care recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
994,756 tubes
Related Recalls
6
3 from same agency
Product description
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA
Reason for recall
Microbial Contamination of Non-Sterile Product
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0247-2019 |
| Date reported | November 14, 2018 |
| Date initiated | September 17, 2018 |
| Recalling firm | Medline Industries Inc |
| Firm location | Northfield, IL |
| Affected scope | 994,756 tubes |
| Distribution | Nationwide USA and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0247-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA. Recalled by Medline Industries Inc. Units affected: 994,756 tubes.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 14, 2018. Severity: Moderate. Recall number: D-0247-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide USA and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0247-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 14, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.