Lower risk Drug recall · FDA · Published May 13, 2021

Accupac Native Fluoride Toothpaste for Sensitive Teeth: Incorrect Labeling Risk

Accupac recalls Native Fluoride Toothpaste for Sensitive Teeth due to potential incorrect labeling as fluoride-free instead of with fluoride. This may lead to improper use for sensitive teeth. Consumers should check labels and contact Accupac for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0598-2021Drug Accupac ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmAccupac, Inc.1501 Industrial Boulevard · Mainland, PA 19451

✎ GovInfoNow plain-language explainer

Accupac is recalling Native Fluoride Toothpaste for Sensitive Teeth because the tube label might incorrectly say 'Fluoride-Free' instead of 'With Fluoride'. This could mean users aren't getting the fluoride they need for sensitive teeth. Read more at govinfonow.com/recall/36138-accupac-native-fluoride-toothpaste-for-sensitive-teeth-incorrect-labeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36138-accupac-native-fluoride-toothpaste-for-sensitive-teeth-incorrect-labeling-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0598-2021

Cite this page

“Accupac Native Fluoride Toothpaste for Sensitive Teeth: Incorrect Labeling Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/36138-accupac-native-fluoride-toothpaste-for-sensitive-teeth-incorrect-labeling-risk. Based on FDA recall #D-0598-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0598-2021%22&limit=1).

The FDA announced on May 13, 2021, that Accupac, Inc. is recalling Native Fluoride Toothpaste for Sensitive Teeth because the primary label may incorrectly identify the product as fluoride-free instead of with fluoride. The recall affects approximately 54,264 tubes distributed nationwide in the U.S. and Puerto Rico.

How to tell if you have it

Brand: Accupac
Product: Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v)
UPC: 0 37000 28803 9
Lot codes: 0317M107 (expiry Oct 12 2022), 1075M107 (expiry Feb 16 2023)
NDC: 69423-903-41
Size: Net Wt. 4.1 oz., 116 g

The hazard

According to the FDA, the hazard is a labeling error where the primary label on the tube may be incorrectly labeled as Fluoride-Free instead of With Fluoride.

How to tell if you have this one

Check the tube label for 'Fluoride-Free' instead of 'With Fluoride'. The product has a net weight of 4.1 oz. and was distributed by Accupac in San Francisco, CA. Lot numbers include 0317M107 (expires Oct 2022) and 1075M107 (expires Feb 2023).

Brand
Accupac
Product
Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Label
Look for the label saying 'Fluoride-Free' instead of 'With Fluoride' on the tube.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Naitonwide in the US and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3 months after the firm started it.

May 13, 2021Firm started the recall
May 26, 2021FDA classified it Class II
Jun 2, 2021Published in FDA’s Enforcement Report
Aug 11, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this toothpaste safe to use?

The toothpaste is safe to use if the label correctly says 'With Fluoride'. If it says 'Fluoride-Free', it may not provide the needed fluoride for sensitive teeth.

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Link to this recall

<a href="https://govinfonow.com/recall/36138-accupac-native-fluoride-toothpaste-for-sensitive-teeth-incorrect-labeling-risk">Accupac Native Fluoride Toothpaste for Sensitive Teeth: Incorrect Labeling Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0598-2021 (May 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0598-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.