The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0598-2021·Announced 2021-06-02

Native Fluoride Toothpaste Recalled for Incorrect Fluoride-Free Labeling

Accupac, Inc. is recalling Native Fluoride Toothpaste for Sensitive Teeth because the primary label may incorrectly state 'Fluoride-Free' instead of 'With Fluoride.'

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding fluoride content, which fits the rubric criteria for minor labeling errors or low-risk contamination.

Plain-English summary

Accupac, Inc. is recalling Native Fluoride Toothpaste for Sensitive Teeth, 4.1 oz. tubes, due to a labeling error. The primary label on the tube may incorrectly identify the product as 'Fluoride-Free' when it actually contains fluoride.

The recall involves 2,261 cases, or 54,264 tubes, distributed nationwide in the US and Puerto Rico. The affected lots are LOT 0317M107 with an expiry date of Oct 12 2022, and LOT1075M107 with an expiry date of Feb 16 2023.

Consumers should check their toothpaste tubes for these specific lot numbers and expiry dates. If the product matches the recalled description, consumers should stop using it and contact the recalling firm for instructions.

The recalled product

Product
Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9
Manufacturer
Accupac, Inc.
Category
Drug — Oral Care
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • LOT 0317M107 with expiry Oct 12 2022 LOT1075M107 with expiry Feb 16 2023

Distribution

Distributed in 1 state:

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