FDAClass IIJune 2, 2021

Native Fluoride Toothpaste for Sensitive Teeth recall: Labeling Error

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…

Why was Native Fluoride Toothpaste for Sensitive Teeth recalled?

Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Accupac, Inc.
Quantity
2,261 cases/24 tubes per case = 54,264 tubes
Distribution
Naitonwide in the US and Puerto Rico.
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls