FDA Toothpaste Recall 2026 Millions of Americans may need to check their bathroom cabinets after the U.S. Food and Drug Administration (FDA) announced a nationwide recall involving more than 4 million tubes of toothpaste. The recall covers 17 product listings, including children’s toothpaste featuring popular characters and adult products marketed for whitening, cavity protection, and sensitive teeth.
The affected products were manufactured by Pritam International Private Limited, an India-based company, and distributed in the United States by Ashtel Studios Inc. The recall was initiated on September 10, 2026, and the FDA classified it as a Class II recall on October 19, 2026, according to published reports.
The agency cited deviations from Current Good Manufacturing Practice (CGMP), which establishes standards for the quality, strength, identity, and purity of drug products. Consumers should check product names and lot numbers carefully because not every tube sold under an affected brand is necessarily included in the recall.
Why Did the FDA Recall More Than 4 Million Toothpaste Tubes?
The recall involves approximately 4.3 million tubes of toothpaste distributed across the United States.
According to the FDA’s recall information, the products did not meet certain Current Good Manufacturing Practice requirements. These standards help ensure that manufacturers follow appropriate procedures when producing and testing products regulated as drugs, including fluoride toothpaste.
The FDA has not publicly identified a specific contaminant as the reason for this recall. Instead, the stated concern involves deviations from manufacturing standards.
The agency assigned the recall a Class II classification. This means that exposure to the affected products may cause temporary or medically reversible health consequences, while the probability of serious adverse health effects is considered remote.
The classification does not mean that every recalled tube is contaminated or that every person who used one will experience a health problem.
Which Toothpaste Brands Are Included in the Recall?
The recall covers 17 product listings sold under several brand names. The affected products include children’s toothpaste, whitening formulas, and products marketed for sensitive teeth or gum health.
| Brand | Recalled product types |
|---|---|
| Brush Buddies | Cavity protection, whitening, and flavored toothpaste |
| Barbie | Bubble gum-flavored anticavity fluoride toothpaste |
| Hot Wheels | Strawberry-flavored anticavity fluoride toothpaste |
| Crayola Silly Scents | Bubble gum, watermelon, and strawberry toothpaste |
| My Little Pony | Bubble gum-flavored toothpaste |
| evo | Advanced Whitening and Sensitive toothpaste |
| ARU | Gum Health and Cavity Protection toothpaste |
Some Brush Buddies products are sold in novelty flavors, including vanilla ice cream, chocolate, mint chocolate chip, and cookies ‘n cream.
The affected products come in different sizes, including 3.5-ounce and 4-ounce tubes. Some cavity-protection toothpaste is also sold in two-tube value packs.
Important: This table identifies the product categories involved, not every individual recalled lot. Check the FDA’s official recall listing for the complete product descriptions, lot codes, expiration dates, and other identifying information.
Are Children’s Toothpaste Products Affected?
Yes. Several products marketed to children are included in the nationwide recall.
The affected varieties include toothpaste featuring Barbie, Hot Wheels, Crayola, and My Little Pony branding. These products are marketed with child-friendly designs and flavors such as bubble gum, strawberry, and watermelon.
Parents and caregivers should inspect toothpaste tubes used by children and compare the packaging with the FDA’s recall information.
Do not assume that a product is safe simply because it has a familiar character or is sold in a children’s oral-care section. The product name, size, and specific lot information are important when determining whether a tube is affected.
If a recalled toothpaste is found in a child’s bathroom or travel bag, stop using it and follow the recommended disposal or return instructions.
Which Adult Toothpaste Products Are Included?
The recall also affects toothpaste marketed to adults.
Some of the included products are sold for advanced whitening, sensitivity relief, cavity protection, and gum health. The affected evo varieties include Advanced Whitening toothpaste in peppermint flavor and Sensitive toothpaste in sweet mint flavor.
Two ARU products are also included: a gum-health formula marketed with nine ingredients and a cavity-protection formula in cool mint.
Certain Brush Buddies adult-oriented formulas, including whitening toothpaste with baking soda and cool mint cavity-protection toothpaste, are also covered.
Because the recall includes multiple formulas and production lots, consumers should not rely on the brand name alone. The exact product and identifying details must match the FDA’s notice.
How to Check Whether Your Toothpaste Is Recalled
Consumers can take a few practical steps to determine whether they have an affected product.
Step 1: Check the brand and product name.
Look for Brush Buddies, Barbie, Hot Wheels, Crayola Silly Scents, My Little Pony, evo, or ARU toothpaste.
Step 2: Check the tube size and packaging.
The recalled products include different sizes and packaging formats. Compare your product with the official FDA listing rather than assuming all products of the same size are affected.
Step 3: Find the lot number and expiration date.
Look at the tube and its packaging for the identifying information. Compare these details with the affected lots listed in the recall notice.
Step 4: Stop using any matching product.
If your toothpaste matches an affected product and lot, discontinue use. Do not continue using it simply because the tube looks normal or has not expired.
Step 5: Check return or refund options.
Contact the retailer or manufacturer for instructions about returning the product or obtaining a refund. Follow the FDA’s official recall information for any additional guidance.
Consumers can consult the FDA’s recall database here:
What Does an FDA Class II Recall Mean?
The FDA uses different recall classifications to communicate the potential health risks associated with affected products.
A Class II recall means that exposure to, or use of, a product may cause temporary or medically reversible health consequences. The likelihood of serious adverse health consequences is considered remote.
Class II does not mean that a product is completely harmless. It also does not establish that every unit in the recall will cause injury.
In this case, the FDA cited deviations from manufacturing standards. Consumers should therefore take the recall seriously, check their products, and avoid using toothpaste that matches the affected lots.
Have Any Illnesses Been Reported?
Reports available at the time of publication stated that no illnesses or injuries had been reported in connection with this toothpaste recall.
However, the absence of reported cases does not mean that affected products should continue to be used. The recall was issued because the products did not meet specified manufacturing requirements.
Anyone who has used a recalled product and is concerned about possible symptoms should contact a healthcare professional for advice.
Parents should also check whether any affected toothpaste is being used by children in their household.
What Should Consumers Do Next?
The most important step is to inspect toothpaste products currently in use and compare them with the official recall notice.
If you find an affected product, stop using it and contact the retailer or manufacturer about disposal, returns, or refunds. Keep the product information available when contacting customer service.
Consumers should also share accurate recall information with family members who may have purchased the affected brands.
The FDA’s action serves as a reminder that manufacturing standards matter even for everyday personal-care products. Checking recall notices and product identification details can help households respond appropriately when a safety concern arises.
1. How many toothpaste tubes have been recalled?
Approximately 4.3 million tubes of toothpaste across 17 product listings are included in the nationwide recall.
2. Which toothpaste brands are affected?
The recall includes products sold under Brush Buddies, Barbie, Hot Wheels, Crayola, My Little Pony, evo, and ARU branding.
3. Why did the FDA issue the toothpaste recall?
The FDA cited deviations from Current Good Manufacturing Practice requirements. The recall notice did not identify a specific contaminant as the cause.
4. Is the toothpaste recall dangerous?
The FDA classified the action as Class II, meaning the products may cause temporary or medically reversible health effects, while the likelihood of serious harm is considered remote. Consumers should stop using any product that matches the recalled lots.
5. What should I do if I have recalled toothpaste?
Stop using the affected product, compare its lot number and expiration date with the official recall listing, and contact the retailer or manufacturer about return or refund options.