TheraBreath for Kids! Oral Rinse 0.05% Recall: Sterility Concern
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…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was TheraBreath for Kids! Oral Rinse 0.05% recalled?
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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
Which lot codes, UPCs or models are affected?
Lot # PA3083011, Exp 3/31/2025
- Agency record number
- D-0046-2024
- 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…
- Recalling firm
- Church & Dwight Inc
- Quantity
- 5,316 bottles
- Distribution
- Nationwide in the US
- Recall started
- September 8, 2023
- Report date
- October 25, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)