# FDA recall D-061-2013

> **Church & Dwight Inc** · Class II · drug recall initiated 2012-09-06.

## Product

Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ  08543; UPC 3 10310 32370 7.

## Reason for recall

CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-061-2013
- **Recalling firm:** Church & Dwight Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-09-06
- **Report date:** 2012-11-28
- **Termination date:** 2013-06-11

- **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-061-2013

## Citation

> AI Analytics. FDA recall D-061-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-061-2013. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
