More Than 4.3 Million Toothpaste Tubes Recalled Nationwide, Including Barbie, Hot Wheels and My Little Pony Kids’ Brands
The FDA has classified a voluntary recall of 17 toothpaste products made by India’s Pritam International Private Limited as Class II, covering more than 4.3 million tubes distributed across the United States — including Brush Buddies children’s toothpastes sold under Barbie, Hot Wheels, Crayola and My Little Pony branding — because of deviations from current good manufacturing practice requirements, according to the FDA’s enforcement report.
What we know / What we don’t know
What we know:
- The FDA’s enforcement report (Event ID 99849) confirms Pritam International Private Limited of Haridwar, India, voluntarily initiated the recall on September 10, 2026, and the FDA classified it as Class II on October 19, 2026.
- The recall covers 17 toothpaste products — recall numbers D-0053-2027 through D-0069-2027 — distributed nationwide in the US by Ashtel Studios Inc. of Ontario, California. The FDA’s product-level figures total 4,301,700 tubes; the event record lists 4,300,147 pieces distributed.
- The reason stated in every product record is “CGMP Deviations.” The FDA told USA Today by email on October 22 that the reason is “deviations from current good manufacturing practice (CGMP) requirements.”
- The biggest single item is Brush Buddies Whitening Anti-cavity Fluoride Toothpaste with Baking Soda in Cool Mint (797,868 tubes), followed by Brush Buddies Hot Wheels (411,600 tubes) and Brush Buddies Barbie (409,800 tubes).
- Class II means the FDA determined that use of or exposure to the product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
- The recall is listed as ongoing, and no press release was issued for it.
What we don’t know:
- What the specific manufacturing deviation was — neither the FDA record nor the agency’s email to USA Today describes the exact failure, and no contaminant has been named.
- Whether any illnesses or adverse events have been reported — none are stated in the FDA record or in the coverage reviewed.
- Why the FDA’s event-level total (4,300,147 pieces) differs slightly from the sum of its product-level quantities (4,301,700 tubes) — the record does not explain the difference.
Key facts
| Detail | Value |
|---|---|
| Products | 17 toothpastes under the Brush Buddies, BB, evo and ARU brands |
| Total volume | 4,301,700 tubes (sum of FDA product-level quantities); 4,300,147 pieces (FDA event record) |
| Recalling firm | Pritam International Private Limited, Haridwar, India |
| US distributor | Ashtel Studios Inc., Ontario, California |
| Recall numbers | D-0053-2027 through D-0069-2027 (FDA Event ID 99849) |
| Classification | Class II, assigned by the FDA on October 19, 2026 |
| Reason | CGMP deviations (deviations from current good manufacturing practice requirements) |
| Recall initiated | September 10, 2026 (voluntary, firm-initiated) |
| Distribution | US nationwide |
| Status | Ongoing |
Background
Anticavity toothpaste is regulated by the FDA as an over-the-counter drug, so it must be made under current good manufacturing practice rules. Those regulations set minimum requirements for the methods, facilities and controls used in manufacturing, processing and packaging, and are designed to ensure a product is safe and has the ingredients and strength it claims. When a process deviates from those requirements, the FDA can classify the resulting recall even when no specific harmful ingredient has been identified in the finished product.
The recalled lines lean heavily on children’s marketing. Alongside the character-licensed Barbie, Hot Wheels, Crayola and My Little Pony tubes, the recall takes in dessert-flavored children’s toothpastes — vanilla ice cream, mint chocolate chip, cookies ‘n cream and chocolate ice cream — plus adult whitening, sensitive and cavity-protection products under the BB, evo and ARU names. All 17 were made by Pritam International in India and distributed in the US by Ashtel Studios.
Timeline
- September 10, 2026: Pritam International Private Limited initiates the voluntary recall.
- October 19, 2026: The FDA classifies the recall as Class II and posts it in its enforcement report.
- October 21–22, 2026: National coverage follows; the FDA confirms to USA Today by email on October 22 that the reason is deviations from CGMP requirements.
Verified details
The FDA record lists the following products, recall numbers and quantities. Every lot code begins with “LWP,” and expiration dates run from November 30, 2026, to December 4, 2028.
| Product | Recall no. | Tubes | UPC |
|---|---|---|---|
| Brush Buddies Whitening Anti-cavity with Baking Soda, Cool Mint, 3.5 oz | D-0065-2027 | 797,868 | 8 50010 84249 3 |
| Brush Buddies Hot Wheels, Strawberry, 4 oz | D-0054-2027 | 411,600 | 8 10147 88047 8 |
| Brush Buddies Barbie, Bubble Gum, 4 oz | D-0053-2027 | 409,800 | 8 10147 88022 5 |
| evo Advanced Whitening, Peppermint, 3.5 oz | D-0059-2027 | 405,336 | 8 10147 88619 7 |
| evo Sensitive, Sweet Mint, 3.5 oz | D-0060-2027 | 389,880 | 8 10147 88620 3 |
| Brush Buddies Crayola Silly Scents, Bubble Gum, 4 oz | D-0055-2027 | 320,232 | 8 50048 32731 3 |
| Brush Buddies Crayola Silly Scents, Watermelon, 4 oz | D-0056-2027 | 320,232 | 8 50048 32730 6 |
| Brush Buddies Crayola Silly Scents, Strawberry, 4 oz | D-0057-2027 | 320,232 | 8 50048 32732 0 |
| BB Cavity Protection, Cool Mint, 2 Value Pack | D-0066-2027 | 231,936 | 8 10147 88543 5 |
| BB Advanced Whitening, Peppermint, 3.5 oz | D-0067-2027 | 198,288 | 8 10147 88542 8 |
| Brush Buddies Vanilla Ice Cream, 3.5 oz | D-0061-2027 | 112,092 | 8 10147 88517 6 |
| Brush Buddies Mint Chocolate Chip Ice Cream, 3.5 oz | D-0062-2027 | 112,092 | 8 10147 88520 6 |
| Brush Buddies Cookies ‘n Cream Ice Cream, 3.5 oz | D-0063-2027 | 112,092 | 8 10147 88519 0 |
| Brush Buddies Chocolate Ice Cream, 3.5 oz | D-0064-2027 | 112,092 | 8 10147 88518 3 |
| Brush Buddies My Little Pony Scents, Bubble Gum, 4 oz | D-0058-2027 | 17,400 | 8 10147 88270 0 |
| ARU Gum Health, Soothing Mint, 3.5 oz | D-0068-2027 | 15,264 | 8 10147 88786 6 |
| ARU Cavity Protection, Cool Mint, 3.5 oz | D-0069-2027 | 15,264 | 8 10147 88785 |
Why it matters
This is the second large FDA-classified recall Daily Trend USA has covered this week, after the recall of Walmart’s Great Value fruit cocktail over possible lead contamination — and it lands differently, because so many products are aimed at children. Character branding and ice-cream flavors are designed to make kids want to brush, and young children are also the users most likely to swallow toothpaste rather than spit it out. Class II is not the FDA’s most serious category, and the agency has not identified a specific contaminant in these tubes. But a manufacturing-practice failure means the controls meant to guarantee what is in every tube did not meet federal requirements, which is why the recall spans the manufacturer’s entire US toothpaste output across four brands rather than a single batch. Parents should check the lot code before the next bedtime brushing.
What to do if you have the product
Check the brand, flavor, lot code and expiration date on your tube against the table above and the FDA record. All recalled lot codes begin with “LWP.” If your tube matches, stop using it. The FDA record publishes no consumer return instructions or company contact for this recall, and no press release was issued; watch the FDA enforcement report entry for updates. If you or your child experience any adverse reaction after using one of these toothpastes, report it through the FDA’s MedWatch program.
What happens next
The recall remains ongoing in the FDA’s system. The agency may update the record with more detail about the deviation, expand or close product entries, and terminate the recall once it is satisfied the products have been removed. Daily Trend USA will update this story if the FDA record changes — the same approach we took with our coverage of the Virginia oyster salmonella recall, where a same-day re-check caught a material change in the case counts.
By the Daily Trend USA Newsroom. Published October 22, 2026. Verification: FDA enforcement report record (Event ID 99849; recall numbers D-0053-2027 through D-0069-2027), read directly in the FDA’s iRES recall database; corroborated by USA Today and PEOPLE. Related coverage: the Walmart Great Value fruit cocktail recall and the Virginia oyster salmonella recall.
