Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sodium Fluoride 1.1% Recalled by AVKARE LLC Due to Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste...

Date: August 11, 2023
Company: AVKARE LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AVKARE LLC directly.

Affected Products

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

Quantity: 35,184 tubes

Why Was This Recalled?

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

Where Was This Sold?

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

About AVKARE LLC

AVKARE LLC has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report