FDA Recall D-0046-2024

Church & Dwight Inc · Princeton, NJ

Class I — life-threatening Ongoing 979 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: Lot # PA3083011, Exp 3/31/2025

Quantity: 5,316 bottles

Reason for recall

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

Recall record

Recall number: D-0046-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2023-09-08
Classified by FDA Center: 2023-10-16
FDA published: 2023-10-25
Recalling firm: Church & Dwight Inc
Firm location: Princeton, NJ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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