FDA Drug recall D-0046-2024
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…
- FDA Drug
- Class I
- ongoing
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class I recall of 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… by Church And Dwight, citing microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0046-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-09-08 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Church And Dwight |
| Distribution | US |
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
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Identifiers
| upc | 697029700006 |
|---|---|
| code_info | Lot # PA3083011, Exp 3/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0046-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.