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
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.
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
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
LABELING: LABEL MIX-UP.
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
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
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.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
CGMP DEVIATIONS
cGMP deviation: Product held outside of appropriate temperature storage conditions.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
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