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

FDA recall notice · announced October 25, 2023 · Church & Dwight

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Reason for recall

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

Notes

Distribution: Nationwide in the US
Lot/code information: Lot # PA3083011, Exp 3/31/2025
Quantity: 5,316 bottles
Status: Ongoing
Products in this recall event:
- 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, N (D-0046-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.