Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
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Contact the company
📍Recalling firmChurch & Dwight Inc469 N Harrison St · Princeton, NJ 08540-3510
✎ GovInfoNow plain-language explainer
Church & Dwight Inc is recalling specific bottles of TheraBreath for Kids! Oral Rinse in the Strawberry flavor because they contain yeast identified as Candida parapsilosis. This microbial contamination means the product is not sterile as intended. The recall affects 5,316 bottles distributed nationwide. Read more at govinfonow.com/recall/33132-therabreath-for-kids-recall-yeast-contamination-risk.
“TheraBreath for Kids Recall: Yeast Contamination Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/33132-therabreath-for-kids-recall-yeast-contamination-risk. Based on FDA recall #D-0046-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0046-2024%22&limit=1).
Church & Dwight Inc is voluntarily recalling TheraBreath for Kids! Oral Rinse due to microbial contamination, the FDA said on Sept. 8, 2023. Owners should stop using the product immediately.
How to tell if you have it
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry
UPC 6 97029 70000 6
Lot # PA3083011
Exp 3/31/2025
The hazard
The product contains yeast identified as Candida parapsilosis, posing a risk of microbial contamination in a non-sterile product.
Context
Church & Dwight Inc has 5 other recalls on record since Sept. 6, 2012. Other recent recalls include the Orajel Baby Swabs Recall (June 6, 2025) and the First Response Pregnancy Test Sticks recall (Jan. 25, 2023). Similar microbial contamination risks have appeared in Medinatura ReBoost Nasal Spray (Dec. 12, 2025), ClearLife Allergy Nasal Spray (Dec. 12, 2025), and Zep Alcohol Sanitizer Spray (May 22, 2026).
How to tell if you have this one
Look for TheraBreath for Kids! Oral Rinse in 16 fl. oz. (473 mL) bottles with Strawberry Splash flavor. Check the label for UPC 6 97029 70000 6 and Lot # PA3083011 with an expiration date of 3/31/2025.
Brand
TheraBreath
Product
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop using the product
Do not use the recalled TheraBreath for Kids! Oral Rinse due to yeast contamination.
Check your bottle details
Verify if your bottle matches Lot # PA3083011 and UPC 6 97029 70000 6.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0046-2024 (September 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0046-2024 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.