CLASS I ONGOING Drug recall · Reported 25 Oct 2023 · FDA Enforcement Report
TheraBreath for Kids! Oral Rinse, sodium fluoride recalled
Church & Dwight is recalling TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), distributed nationwide in the US. The recall was initiated on 8 Sep 2023 and the FDA has classified it as Class I.
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-0046-2024
- FDA event ID
- 93007
- Recalling firm
- Church & Dwight, Princeton, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Sep 2023
- FDA classified
- 16 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
Timeline
| 8 Sep 2023 | Recall initiated by company | |
| 16 Oct 2023 | Classified by FDA | +38 days |
| 25 Oct 2023 | Published in enforcement report | +9 days |
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; presence of yeast identified as Candida parapsilosis
Product as listed by the FDA
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Which lots are affected?
Lot # PA3083011, Exp 3/31/2025
Where was it sold?
Nationwide in the US
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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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