CLASS II Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report
SparkleFresh Fluoride Toothpaste recalled by Medline Industries
Medline Industries is recalling SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) tube (, distributed nationwide in the US. The recall was initiated on 17 Sep 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0247-2019
- FDA event ID
- 81381
- Recalling firm
- Medline Industries, Northfield, IL
- Brand
- Sparklefresh
- Manufacturer
- Medline Industries, LP
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Sep 2018
- FDA classified
- 15 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Sunscreen & Personal Care
Timeline
| 17 Sep 2018 | Recall initiated by company | |
| 14 Nov 2018 | Published in enforcement report | +58 days |
| 15 Nov 2018 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Product
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Product
Which lots are affected?
a) Lot 102920C, exp 10/29/2020 and 111220C, exp 11/11/2020; b) 111620D, exp 11/16/2020; c) 111420D, exp 11/14/2020; d) 111720C, exp 11/17/2020
Where was it sold?
Nationwide USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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