TheraBreath for Kids Oral Rinse Recalled for Yeast Contamination
FDA recalls TheraBreath for Kids Oral Rinse due to microbial contamination identified as Candida parapsilosis yeast. Approximately 5,316 bottles distributed nationwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity of 4 per the rubric. The presence of confirmed Candida parapsilosis contamination in a product intended for children justifies the Severe rating. No illnesses or injuries have been reported in the source text.
Plain-English summary
TheraBreath for Kids! Oral Rinse is being recalled due to microbial contamination. Testing identified the presence of yeast identified as Candida parapsilosis in the product.
The recalled product is the Strawberry Splash flavor, available in 16 fl. oz. (473 mL) bottles manufactured by Church & Dwight Co, Inc., Ewing, NJ. The affected lot number is PA3083011 with an expiration date of March 31, 2025 (UPC 6 97029 70000 6).
The product was distributed nationwide in the United States. A total of 5,316 bottles are included in this recall.
The recalled product
- Product
- 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
- Manufacturer
- Church & Dwight Inc
- Category
- Drug — Mouthwash
- Affected units
- 5,316
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # PA3083011
- Exp 3/31/2025
Distribution
Distributed nationwide across the United States.
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