CLASS III Drug recall · Reported 22 Mar 2017 · FDA Enforcement Report
PreviDent 5000 ppm, Dry Mouth, 1.1% Sodium Fluoride recalled
Colgate Palmolive is recalling PreviDent 5000 ppm, Dry Mouth, 1.1% Sodium Fluoride, Prescription Strength Toothpaste, distributed nationwide in the US. The recall was initiated on 13 Feb 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0521-2017
- FDA event ID
- 76516
- Recalling firm
- Colgate Palmolive, New York, NY
- Brand
- Prevident
- Manufacturer
- Colgate Oral Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Feb 2017
- FDA classified
- 15 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Sunscreen & Personal Care
Timeline
| 13 Feb 2017 | Recall initiated by company | |
| 15 Mar 2017 | Classified by FDA | +30 days |
| 22 Mar 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Which lots are affected?
Lots: 6350US561G, 6350US562G, 6351US561G, 6351US562G
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Sodium Fluoride recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Fluoride 1.1%, Sodium Fluoride Prescription Dental recalledSodium Flouride | Avkare | Other | TN |
| Drug | CLASS II | biotene Gentle Formula Fluoride Toothpaste Fresh Mint recalledBiotene | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |
| Drug | CLASS II | biotene Gentle Formula Fluoride Toothpaste Gentle Mint tubes recalledBiotene | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |