# FDA recall D-0046-2024

> **Church & Dwight Inc** · Class I · drug recall initiated 2023-09-08.

## 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

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0046-2024
- **Recalling firm:** Church & Dwight Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-09-08
- **Report date:** 2023-10-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0046-2024

## Citation

> AI Analytics. FDA recall D-0046-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0046-2024. Source: US FDA. Licensed CC0.

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