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
PreviDent 5000 ppm (Sodium Fluoride)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622
Affected NDC
0126-0016-61
Compare with the code on your package — it is the most precise check available.
Drug: Fluoride
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| PreviDent 5000 Dry Mouth Sodium fluoride NDC 00126-0016 |
6.1 mg/mL | Gel, Dentifrice Dental |
Colgate Oral Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Colgate Palmolive Co
- NDC code
- 0126-0016-61
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0521-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Other recalls by Colgate Palmolive Co
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Class II · Moderate risk
hello wild strawberry fluoride toothpaste
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