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More Than 4.3 Million Tubes of Toothpaste, Including Children’s Varieties Featuring Popular Characters, Were Recalled—What Families Should Know About the FDA’s Class II Classification

More than 4.3 million tubes of toothpaste are under an FDA Class II recall, and the detail families are most likely to recognize is the branding: Brush Buddies kids’ toothpaste sold with Barbie, Hot Wheels, My Little Pony and Crayola Silly Scents tie-ins.

Here’s what’s actually in the FDA’s own enforcement report, who’s behind the recall, and what the “Class II” label does and doesn’t mean for a tube that might already be in your bathroom.

Who’s behind the recall

The products were manufactured by Pritam International Private Limited and distributed in the U.S. by Ashtel Studios Inc., based in Ontario, California. The recall covers three product lines: Brush Buddies kids’ toothpaste in the Barbie, Hot Wheels, My Little Pony and Crayola Silly Scents varieties; Evo advanced-whitening and sensitive toothpaste; and ARU gum-health and cavity-protection toothpaste.

Why it was recalled

According to the FDA’s enforcement report (Event ID 99849), the issue traces to deviations from Current Good Manufacturing Practice, the FDA’s baseline manufacturing-quality standard. The public report doesn’t spell out the specific defect behind those deviations, and neither Ashtel Studios nor Pritam International has published further detail beyond what’s in the enforcement record.

What “Class II” actually means

The FDA sorts recalls into three risk tiers. Class I covers situations where use of a product could cause serious health consequences or death. Class II, the tier this recall falls under, covers situations where use may cause temporary or medically reversible health consequences, with a remote probability of serious harm. Class III covers products unlikely to cause any adverse health consequences at all.

In plain terms, a Class II classification means the FDA sees a real but limited risk, not an emergency.

Key dates

Ashtel Studios voluntarily initiated the recall on September 10, 2026. The FDA classified it Class II on October 19, 2026. The affected products were sold nationwide.

What to do if you have one of these tubes

Stop using the product and check the FDA’s enforcement report for the specific lot numbers covered, since not every lot of every listed product is included. Most people who’ve used a recalled tube won’t have any symptoms at all, consistent with the Class II risk level. Watch for mouth, gum or lip irritation; if it appears, stop use and check with a pediatrician or pediatric dentist.

For a refund or replacement, contact the company through the customer-service information printed on the package, since that’s the channel Ashtel Studios has set up to handle the recall directly.

The bottom line

This is a real, FDA-classified recall covering brands built around characters a lot of kids recognize by name, Barbie, Hot Wheels, My Little Pony and Crayola among them, which is exactly why the packaging is worth a second look. The practical step is simple: check the lot number on your tube against the FDA’s enforcement report, Event ID 99849, before the next brushing.

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