Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Fluoride recalled?

Yes — there is an active recall. 9 ongoing FDA recalls mention Fluoride (45 total). Check the affected lots below.

Most common reason: cGMP deviation (14 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluoride. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Fluoride recalls on record

none so far in 2026; 45 on record, newest first
Class III · Low risk

Sensodyne PRONAMEL

Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton

Ongoing Labeling / mix-up Haleon US Holdings LLC D-0592-2025
Class II · Moderate risk

Nature Mint

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-05 D-0440-2025
Class II · Moderate risk

Nature Mint

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-07 D-0437-2025
Class II · Moderate risk

Nature Mint

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-02 D-0436-2025
Class II · Moderate risk

Nature Mint

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-06 D-0435-2025
Class II · Moderate risk

Maximum Security

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-132-04 D-0434-2025
Class II · Moderate risk

Maximum Security

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-132-01 D-0433-2025
Class II · Moderate risk

Maximum Security

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-132-03 D-0432-2025
Class II · Moderate risk

Sodium Fluoride 1.1%

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

Terminated Labeling / mix-up Avkare LLC NDC 42291-741-51 D-1146-2023
Class II · Moderate risk

hello wild strawberry fluoride toothpaste

Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.

Terminated Labeling / mix-up Colgate Palmolive Company D-1084-2023
Class II · Moderate risk

activator concentrate

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Completed cGMP deviation Ecometics, Inc. D-1100-2023