FDA classifies recall of 4.3 million toothpaste tubes as Class II

The Food and Drug Administration classified a nationwide recall of more than 4.3 million tubes of fluoride toothpaste as Class II on Oct. 19, a mid-level risk rating covering 17 products, many of them marketed to children.

Pritam International Private Limited, an India-based manufacturer, began the voluntary recall on Sept. 10. The products were distributed in the United States by Ashtel Studios Inc. of Ontario, California, and sold nationwide. The FDA notice does not mention any illnesses or injuries.

The recall was entered in the agency's enforcement report for deviations from current good manufacturing practice, the federal rules covering how drugs are made.

Seventeen products, many for children

The list includes Brush Buddies children's toothpastes carrying Barbie, Hot Wheels, My Little Pony and Crayola Silly Scents branding, along with adult products sold for sensitive teeth or whitening. The adult lines are evo Sensitive and evo Advanced Whitening, ARU Cavity Protection and ARU Gum Health, and BB Advanced Whitening and BB Cavity Protection, the last sold as a two-pack.

Flavors in the notice include bubble gum, strawberry, watermelon, peppermint, sweet mint and cool mint. The listing also covers dessert varieties sold under the Brush Buddies name, among them vanilla ice cream, chocolate ice cream, mint chocolate chip and cookies and cream.

The recalled tubes come in 3.5-ounce and 4-ounce sizes, along with a value pack holding two 3.5-ounce tubes with a combined weight of 7 ounces.

Recall Canary, which summarizes FDA notices, lists an active ingredient for each item. Several of the children's pastes contain sodium fluoride at 0.243 percent, and the evo Sensitive paste carries potassium nitrate at 5 percent alongside sodium fluoride at 0.24 percent. The Brush Buddies whitening paste with baking soda uses sodium monofluorophosphate at 0.76 percent, and ARU Gum Health uses stannous fluoride at 0.45 percent.

Lot numbers decide the match

Not every tube of these varieties is recalled: the FDA notice covers selected lots rather than whole product lines, and the lot code printed on the tube decides it.

Consumers should check the lot numbers on their tubes because not all lots are recalled, the Deseret News reported, and the full list of affected products is posted on the FDA website.

A product is affected only if its lot code and its NDC or UPC are listed under that product, according to Recall Canary's summary of the notice. A UPC is the number printed under a barcode, and an NDC, or National Drug Code, usually appears on the drug's label.

Lot codes on the recalled tubes begin with the letters LWP followed by a string of digits, and several end with a letter. One code, LWP250037221405, is listed under four of the ice cream flavored pastes: cookies 'n cream, vanilla, chocolate and mint chocolate chip.

What the notice does not say

No specific explanation of what happened during manufacturing was given, the Deseret News reported. In the enforcement listing summarized by Recall Canary, each entry carries the same reason, CGMP deviations, with no account of how the problem was found or which step of production it touched.

The recall notice does not include specific instructions for consumers, NBC News reported, and neither the manufacturer nor the distributor had issued public guidance on returns or refunds when the outlet published on Oct. 23.

Recall Canary said it had no product-specific instructions for this recall and pointed to the agency's general advice for medicine recalls. That advice is to check the FDA or company notice for instructions specific to the product and to ask a pharmacist or doctor whether a particular lot is affected.

Pritam International started the recall itself, and the agency's recorded action in the file so far is the classification it issued on Oct. 19.

The standard at issue

Current good manufacturing practice rules are federal standards meant to ensure products are made consistently and safely, NBC News reported, so a deviation means the manufacturing process did not meet those requirements.

The FDA's figure of more than 4.3 million tubes covers the 17 products together rather than any single brand or size.

A deviation means the process fell short, not necessarily that the toothpaste itself is harmful, NBC News reported.

How the agency ranks recalls

Class II is a mid-level risk classification, the Deseret News reported, and recalls judged to carry a high health risk are placed in Class I instead. The agency's definition of the middle tier turns on whether any harm would be temporary or reversible, and on how likely serious harm is.

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

Accounts of the plant differ. NBC News reported that the FDA flagged manufacturing problems at the facility that made the toothpaste, while WDIV reported that the problems were at the facility that packaged it. Neither description went further than that.

Expiration dates on the affected tubes run from November 2026 through June 2028. NBC News noted that the later dates mean some of the recalled toothpaste could still be sitting in medicine cabinets.

What consumers are told to do

A tube is checked by matching its brand and lot code against the FDA's recall notice, along with the expiration date on the packaging. The agency says families should run that check to see whether their toothpaste is part of the recall. WJXT reported that consumers whose product matches should stop using it and contact the retailer or the manufacturer about returns or refunds.

The Deseret News reported that consumers can throw the recalled product out or contact the retailer or manufacturer about returns or refunds. NBC News, citing the absence of published instructions, told readers to stop using the toothpaste immediately and discard it, and to keep a receipt or a photograph of the packaging in case a refund process is announced later.

Anyone who used one of the products and has concerns should contact a dentist or doctor, NBC News said in its report on the recall.

Whether Pritam International or Ashtel Studios will set up a returns process is unresolved in the public record. The classification issued on Oct. 19 is the most recent step the FDA has recorded, and its listing continues to carry the lot codes and the product identifiers for all 17 items.