CLASS II Drug recall · Reported 28 Nov 2012 · FDA Enforcement Report
Orajel Kids My Way! Anticavity Fluoride recalled by Church & Dwight
Church & Dwight is recalling Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24% pump, Church, distributed nationwide in the US. The recall was initiated on 6 Sep 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-061-2013
- FDA event ID
- 62461
- Recalling firm
- Church & Dwight, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2012
- FDA classified
- 21 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Sunscreen & Personal Care
Timeline
| 6 Sep 2012 | Recall initiated by company | |
| 21 Nov 2012 | Classified by FDA | +76 days |
| 28 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Which lots are affected?
Lot #: BI1041, Exp 02/13
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Church & Dwight
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|---|---|---|---|---|---|
| Drug | CLASS II | Zicam, Cold Remedy, Medicated Nasal Swabs recalled by Church & Dwight Co | Church & Dwight | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zicam" Medicated Fruit Drops Elderberry Flavor, 25-drops recalledZicam Cold Remedy Medicated Fruit Drops - Elderberry | Church & Dwight | Packaging Defects | Nationwide |
| Drug | CLASS I | Zicam Nasal All recalled by Church & Dwight | Church & Dwight | Sterility | Nationwide |
| Drug | CLASS I | Zicam Cold Remedy Medicated Nasal Swabs-Use Swabs recalled | Church & Dwight | Sterility | Nationwide |
| Drug | CLASS I | Orajel Baby, Cooling Swabs for Teething, Each Unit recalled | Church & Dwight | Sterility | Nationwide |