Orajel Kids Toothpaste Recalled for Incorrect Ingredient Substitution
Church & Dwight is recalling Orajel Kids My Way! toothpaste because Laureth-9 was mistakenly substituted for PEG during manufacturing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is a manufacturing deviation (incorrect ingredient) rather than a high-risk pathogen or structural defect.
Plain-English summary
Church & Dwight Inc. is recalling 42,768 pumps of Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump. The product is identified by Lot # BI1041 and an expiration date of 02/13. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.
The recall is necessary because the product was made with an incorrect ingredient. Specifically, Laureth-9 was mistakenly substituted for PEG during the manufacturing process. The affected toothpaste was distributed nationwide.
Consumers who have this specific lot of toothpaste should stop using it and return it to the place of purchase for a refund or contact Church & Dwight Inc. for further instructions.
The recalled product
- 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.
- Manufacturer
- Church & Dwight Inc
- Category
- Drug — Toothpaste
- Hazard
- Affected units
- 42,768
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: BI1041
- Exp 02/13
Distribution
Distributed nationwide across the United States.
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