CLASS III Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report
Denblan Anticavity Fluoride Toothpaste, Whitening formula recalled
Estee Lauder is recalling Denblan Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 76%, distributed nationwide in the US. The recall was initiated on 6 Jun 2014 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-1452-2014
- FDA event ID
- 68449
- Recalling firm
- Estee Lauder, New York, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Jun 2014
- FDA classified
- 24 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Sunscreen & Personal Care
Timeline
| 6 Jun 2014 | Recall initiated by company | |
| 24 Jul 2014 | Classified by FDA | +48 days |
| 30 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stability Data Does Not Support Expiry
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France
Where it was distributed
Nationwide
Questions about this recall
Is Denblan Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 76% recalled?
Yes. Estee Lauder recalled Denblan Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 76% on 6 Jun 2014. The recall is Class III and its status is Terminated. Recall number D-1452-2014.
Why was it recalled?
Stability Data Does Not Support Expiry
Which lots are affected?
All lot codes and shipment dates are being recalled. 2.6oz/75ml. in a light green carton, UPC: 8-82381-07901-7 Code: D079-01-1000
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Estee Lauder
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF recalled | Estee Lauder | Packaging Defects | Nationwide |
| Drug | CLASS III | DayWear Sheer Tint Release, Advanced Multi-Protection recalled | Estee Lauder | Potency & Assay | Nationwide |