Class I Recall for Contaminated Mouthwash

More than 5000 bottles of TheraBreath Strawberry Splash for Kids are under a Class I recall due to microbial contamination with yeast (Candida parapsilosis). The recall appears in the October 25, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall classification is the FDA’s most serious and warns use of the recalled product could cause major adverse health consequences or death.

“The use of the affected product in immune-compromised individuals could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection,” recalling firm Church & Dwight Co. announced in a September 13, 2023, statement. “In nonimmunocompromised individuals who recently underwent oral surgery or dental procedures resulting in mucosal barrier disruption (eg, tooth extraction), the use of the defective product may result in infectious complications, but in this population the infections may be less severe and may be more readily responsive to treatment.”

The recall affects 16-ounce bottles of TheraBreath Strawberry Splash for Kids (UPC 6 97029 70000 6) from lot PA3083011 (Exp. 3/31/25). The product was manufactured for Church & Dwight Co., Ewing, New Jersey, and sold exclusively on Amazon between May 31, 2023, and September 2, 2023. The affected product was distributed throughout the US.

Church & Dwight Co. voluntarily initiated the recall September 8, 2023. The FDA issued its Class I designation October 16, 2023.

TheraBreath Strawberry Splash for Kids is indicated as an anticavity mouthwash for adults and children 6 years of age and older.