Orajel Kids Toothpaste Recall: Incorrect Ingredient
Church & Dwight recalls Orajel Kids My Way! Anticavity Fluoride toothpaste due to CGMP deviations involving an incorrect ingredient substitution.
Use caution until it’s fixed
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Contact the company
What happened, in plain English
Church & Dwight Inc. is recalling Orajel Kids My Way! Anticavity Fluoride toothpaste because it was manufactured with an incorrect ingredient. Laureth-9 was mistakenly substituted for PEG during production. This constitutes a deviation from Current Good Manufacturing Practices (CGMP). Read more at govinfonow.com/recall/48566-church-dwight-inc-recalls-orajel-kids-my-way-anticavity-fluoride.
Source Summary by GovInfoNow · govinfonow.com/recall/48566-church-dwight-inc-recalls-orajel-kids-my-way-anticavity-fluoride · Updated October 13, 2026 · FDA enforcement record: FDA #D-061-2013
Cite this page
“Orajel Kids Toothpaste Recall: Incorrect Ingredient.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48566-church-dwight-inc-recalls-orajel-kids-my-way-anticavity-fluoride. Based on FDA recall #D-061-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-061-2013%22&limit=1).
Why it’s dangerous
The hazard stems from a manufacturing error where Laureth-9 was used instead of the intended PEG ingredient. While the record does not specify immediate physical injury, the substitution represents a quality control failure that could affect product safety and efficacy.
Who’s affected
Parents and caregivers who purchased Orajel Kids My Way! Anticavity Fluoride toothpaste nationwide between the manufacturing date and the recall announcement are likely affected. Children using this specific product are at risk of exposure to the incorrect ingredient.
How to tell if you have this one
Check for Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste in a 3 oz (85 g) pump bottle. Look for UPC 3 10310 32370 7 and Lot # BI1041 with an expiration date of 02/13.
- Brand
Orajel- Product
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col- Category
Drug
What to do — step by step
Stop Using the Product
Cease use of the recalled Orajel Kids My Way! toothpaste immediately if you have Lot # BI1041.
Contact Manufacturer
Reach out to Church & Dwight Inc. for further instructions on disposal or return.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many units of this product were recalled?
Approximately 42,768 pumps were included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-061-2013 (September 6, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-061-2013 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.