Orajel Kids My Way! Anticavity Fluoride — Class II drug recall D-061-2013
Terminated recall by Church & Dwight Inc, reported 2012-11-28, distributed nationwide. CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
| Recall number | D-061-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Church & Dwight Inc, Princeton, NJ, United States |
| Recall initiated | 2012-09-06 |
| Classified | 2012-11-21 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 42,768 pumps |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00310310323707 |
| Lot numbers | 02/13, BI1041 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-061-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.