CLASS II Drug recall · Reported 19 Aug 2015 · FDA Enforcement Report
biotene Gentle Formula Fluoride Toothpaste Gentle Mint tubes recalled
GlaxoSmithkline Consmer Healthcare is recalling biotene Gentle Formula Fluoride Toothpaste Gentle Mint tubes, distributed nationwide in the US. The recall was initiated on 15 Jul 2015 and the FDA has classified it as Class II.
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-1319-2015
- FDA event ID
- 71750
- Recalling firm
- GlaxoSmithkline Consmer Healthcare, Moon Township, PA
- Brand
- Biotene
- Manufacturer
- Haleon US Holdings LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jul 2015
- FDA classified
- 11 Aug 2015
- Reported
- 19 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Sunscreen & Personal Care
Timeline
| 15 Jul 2015 | Recall initiated by company | |
| 11 Aug 2015 | Classified by FDA | +27 days |
| 19 Aug 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
Where it was distributed
Nationwide, Puerto Rico & Taiwan
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Which lots are affected?
Lot # Y3E211, Exp 04/16 Y3G231, Y3G251, Exp 06/16 Y3J231,Y3N191 Exp 08/16 Y3N171, Exp 11/16 Y4A141, Exp 12/16 Y4C271, Exp 02/17 Y4E131, Exp 04/17 Y4G101, Exp 05/17 Y4H191, Exp 06/17
Where was it sold?
Nationwide, Puerto Rico & Taiwan
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
7 other products · FDA event 71750This product is part of a recall event; the main page for the event is Sensodyne Extra Fresh Repair & Protect tubes recalled.
More recalls from GlaxoSmithkline Consmer Healthcare
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sensodyne With Fluoride Repair & Protect, a) tubes recalledSensodyne | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |
| Drug | CLASS II | biotene Gentle Formula Fluoride Toothpaste Fresh Mint recalledBiotene | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |
| Drug | CLASS II | biotene Gentle Mint Gel tubes recalled by GlaxoSmithkline Consmer | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |
| Drug | CLASS II | biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula) recalled | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |
| Drug | CLASS II | Sensodyne Complete PROTECTIONtubes recalled by GlaxoSmithkline ConsmerSensodyne Complete Protection | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |
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 III | PreviDent 5000 ppm, Dry Mouth, 1.1% Sodium Fluoride recalledPrevident | Colgate Palmolive | Labeling Errors | Nationwide |
| Drug | CLASS II | biotene Gentle Formula Fluoride Toothpaste Fresh Mint recalledBiotene | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |