TheraBreath for Kids! Oral Rinse Recalled for Microbial Contamination

Agency Publication Date: October 16, 2023

Summary

Church & Dwight Inc. is recalling 5,316 bottles of TheraBreath for Kids! Oral Rinse (sodium fluoride 0.05%) in Strawberry Splash flavor. Testing discovered microbial contamination in the non-sterile product, specifically identifying the presence of a yeast called Candida parapsilosis. The recall affects 16 fl. oz. (473 mL) bottles distributed across the United States.

Risk

The product is contaminated with Candida parapsilosis yeast. Using a contaminated oral rinse can lead to infections, especially in children or individuals with compromised immune systems or pre-existing oral health conditions.

What You Should Do

The recalled product is TheraBreath for Kids! Oral Rinse (sodium fluoride 0.05%) in Strawberry Splash flavor, sold in 16 fl. oz. (473 mL) bottles.
Identify affected bottles by checking for UPC 6 97029 70000 6, lot number PA3083011, and an expiration date of 3/31/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Church & Dwight Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: TheraBreath for Kids! Oral Rinse (16 fl. oz.)

Variants: Strawberry Splash, 0.05% sodium fluoride

UPC Codes:

697029700006

Lot Numbers:

PA3083011 (Exp 3/31/2025)

Manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628

Product Images

TheraBreath for Kids! anti cavity oral rinse, Strawberry Splash

UPC code found on the product label, below the barcode

Lot Code and Expiry date on bottom of the bottle

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93007

Status: Active

Manufacturer: Church & Dwight Inc

Manufactured In: United States

Units Affected: 5,316 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled product is TheraBreath for Kids! Oral Rinse (sodium fluoride 0.05%) in Strawberry Splash flavor, sold in 16 fl. oz. (473 mL) bottles.

Identify affected bottles by checking for UPC 6 97029 70000 6, lot number PA3083011, and an expiration date of 3/31/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Church & Dwight Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.