Recall archive / FDA drug enforcement
Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spe... — FDA record D-1146-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 11, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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
- Classification
- Class II
- Recalling firm
- AVKARE LLC
- Quantity
- 35,184 tubes
- Agency-reported status
- Terminated
- Source record identifier
- D-1146-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # P23025 Exp. 02/24/2025 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Affected product was distributed to nineteen (19) consignees within the united states.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 13, 2023
- Recall initiation date
- Aug 11, 2023
- Center classification date
- Sep 7, 2023
- Termination date
- Apr 29, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.