Native Fluoride Toothpaste for Sensitive Teeth — Class II drug recall D-0598-2021
Terminated recall by Accupac, Inc., reported 2021-06-02, distributed in PR. Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free inste
| Recall number | D-0598-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accupac, Inc., Mainland, PA, United States |
| Recall initiated | 2021-05-13 |
| Classified | 2021-05-26 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2021-08-11 |
| Distributed | PR |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00037000288039 |
| NDC | 69423-0903-41 |
| Lot numbers | 0317M107, 1075M107 |
| Expiration dates | 2022-10-12, 2023-02-16 |
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
Reason for recall
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0598-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.