Author: FFP Ai Bot

WASHINGTON — More than 4 million tubes of fluoride toothpaste sold across the country, including children’s Brush Buddies tubes with Barbie, Hot Wheels, My Little Pony and Crayola branding, are part of a voluntary recall listed by the U.S. Food and Drug Administration.

The recall covers 17 products. Added together, the quantities in the FDA listings come to about 4.3 million tubes. The products were distributed nationwide by Ashtel Studios Inc. of Ontario, California. The recalling firm named in the FDA listings is the manufacturer, Pritam International Private Limited, of Haridwar, India.

Why it was recalled

The FDA lists the reason as “CGMP Deviations,” meaning the products were not made in full compliance with current good manufacturing practice rules. The agency has not said what specific problem was found. Because fluoride is an active ingredient, fluoride toothpaste is regulated as an over-the-counter drug in the United States.

The recall began Sept. 10, 2026, and was classified as a Class II recall this week. The FDA uses Class II for situations where a product may cause temporary or medically reversible health problems and the chance of serious harm is remote. FFP found no reports of injuries tied to these products.

Products on the recall list

Brush Buddies (4.0 oz unless noted)

• Barbie Anticavity Fluoride Toothpaste, Bubble Gum – NDC 84140-001-40 – 409,800 tubes
• Hot Wheels Anticavity Fluoride Toothpaste, Strawberry – NDC 84140-002-40 – 411,600 tubes
• Crayola Silly Scents, Bubble Gum – NDC 84140-003-40 – 320,232 tubes
• Crayola Silly Scents, Watermelon – NDC 84140-004-40 – 320,232 tubes
• Crayola Silly Scents, Strawberry – NDC 84140-005-40 – 320,232 tubes
• My Little Pony, Bubble Gum – NDC 84140-008-40 – 17,400 tubes
• Vanilla Ice Cream flavored (3.5 oz) – NDC 84140-517-35 – 112,092 tubes
• Mint Chocolate Chip Ice Cream flavored (3.5 oz) – NDC 84140-520-35 – 112,092 tubes
• Cookies ‘n Cream Ice Cream flavored (3.5 oz) – NDC 84140-519-35 – 112,092 tubes
• Chocolate Ice Cream flavored (3.5 oz) – NDC 84140-518-35 – 112,092 tubes
• Whitening with Baking Soda, Cool Mint (3.5 oz) – NDC 84140-007-07 – 797,868 tubes

evo (3.5 oz)

• Advanced Whitening, Peppermint – NDC 84140-886-19 – 405,336 tubes
• Sensitive, Sweet Mint – NDC 84140-620-35 – 389,880 tubes

BB (3.5 oz)

• Cavity Protection, Cool Mint, 2-pack – NDC 84140-035-10 – 231,936 tubes
• Advanced Whitening, Peppermint – NDC 84140-885-42 – 198,288 tubes

ARU (3.5 oz)

• Gum Health, Soothing Mint – NDC 84140-786-35 – 15,264 tubes
• Cavity Protection, Cool Mint – NDC 84140-785-35 – 15,264 tubes

Each product’s FDA listing gives its own lot numbers and expiration dates. For example, the Barbie Bubble Gum listing (item 88022, UPC 8 10147 88022 5) includes lots LWP250035710304A (exp. 04/27/2027), LWP250037812105 (exp. 06/03/2027), LWP250045750310 (exp. 02/19/2028) and LWP260055421803 (exp. 05/13/2028), among others. Check the lot code printed on your tube’s crimped end or box against the full list in the FDA Enforcement Report database. Search for “Ashtel” or “Brush Buddies,” or use recall numbers D-0053-2027 through D-0069-2027.

What to do

• Look at the brand, flavor and lot number on any Brush Buddies, evo, BB or ARU toothpaste at home.
• If the lot matches, stop using that tube.
• Ask the store where you bought it, or contact the company, about a return or refund.
• If you are worried about a reaction after using a product, call a doctor or pharmacist. Problems with FDA-regulated products can be reported to the agency’s MedWatch program.

More on how recalls are classified is on the FDA’s Enforcement Reports page.

Sources

https://www.accessdata.fda.gov/scripts/ires/index.cfm
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports
https://www.13abc.com/2026/10/22/more-than-4-million-tubes-toothpaste-including-popular-childrens-brand-recalled/
https://www.abc10.com/article/news/nation-world/toothpaste-recall-list-brush-buddies-evo-aru/507-eba20cac-f7d6-45d5-af44-49f612d9d3b9