CLASS II Drug recall · Reported 13 Sep 2023 · FDA Enforcement Report
Sodium Fluoride 1.1%, Sodium Fluoride Prescription Dental recalled
Avkare is recalling Sodium Fluoride 1.1%, Sodium Fluoride Prescription Dental Toothpaste, 5000 ppm Fluoride. The recall was initiated on 11 Aug 2023 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-1146-2023
- FDA event ID
- 92868
- Recalling firm
- Avkare, Pulaski, TN
- Brand
- Sodium Flouride
- Manufacturer
- AvKARE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Aug 2023
- FDA classified
- 7 Sep 2023
- Reported
- 13 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Sunscreen & Personal Care
Timeline
| 11 Aug 2023 | Recall initiated by company | |
| 7 Sep 2023 | Classified by FDA | +27 days |
| 13 Sep 2023 | 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
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
Product as listed by the FDA
Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478
Where it was distributed
Affected product was distributed to nineteen (19) consignees within the united states.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot # P23025 Exp. 02/24/2025
Where was it sold?
Affected product was distributed to nineteen (19) consignees within the united states.
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
1 other product · FDA event 92868This product is part of a recall event; the main page for the event is Capsaicin Cream 0.025%, External Analgesic Cream recalled by AVKARE.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Capsaicin Cream 0.025%, External Analgesic Cream recalled by AVKARECapsaicin | Avkare | Packaging Defects | TN |
More recalls from Avkare
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Sodium Fluoride recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | biotene Gentle Formula Fluoride Toothpaste Gentle Mint tubes recalledBiotene | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |