TheraBreath for Kids! Oral Rinse — Class I drug recall D-0046-2024
Ongoing recall by Church & Dwight Inc, reported 2023-10-25, distributed nationwide. Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
| Recall number | D-0046-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Church & Dwight Inc, Princeton, NJ, United States |
| Recall initiated | 2023-09-08 |
| Classified | 2023-10-16 |
| Reported by FDA | 2023-10-25 |
| Distributed | Nationwide (US) |
| Quantity | 5,316 bottles |
| Reason classes | microbial contamination, sterility |
| Pathogens | yeast |
| UPC / GTIN / UDI-DI | 00697029700006 |
| Lot numbers | PA3083011 |
| Expiration dates | 2025-03-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0046-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.