FDAClass IOctober 25, 2023

TheraBreath for Kids! Oral Rinse 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…

Why was TheraBreath for Kids! Oral Rinse recalled?

Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # PA3083011, Exp 3/31/2025

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 date
October 25, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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