Recalls / Class I
Class ID-0046-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot # PA3083011, Exp 3/31/2025
Why it was recalled
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Recalling firm
- Firm
- Church & Dwight Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 469 N Harrison St, N/A, Princeton, New Jersey 08540-3510
Distribution
- Quantity
- 5,316 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2023-09-08
- FDA classified
- 2023-10-16
- Posted by FDA
- 2023-10-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0046-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.