---
title: "Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 pp... — FDA record D-1146-2023 | Is It on Recall"
description: "Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium"
url: https://isitonrecall.com/recall/fda-drug-d-1146-2023-sodium-fluoride-1-1-sodium-fluoride-prescription-dental-toothpaste-5000-ppm-fluoride-plus-mild-clean/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spe... — FDA record D-1146-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 11, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478
- **Reason**: Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
- **Classification**: Class II
- **Recalling firm**: AVKARE LLC
- **Quantity**: 35,184 tubes
- **Agency-reported status**: Terminated
- **Source record identifier**: D-1146-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1146-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot # P23025 Exp. 02/24/2025 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Affected product was distributed to nineteen (19) consignees within the united states.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Sep 13, 2023
- **Recall initiation date**: Aug 11, 2023
- **Center classification date**: Sep 7, 2023
- **Termination date**: Apr 29, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1146-2023%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [AVKARE LLC records](https://isitonrecall.com/brand/avkare-llc/)