FDA Drug recall D-1146-2023
Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ.…
- FDA Drug
- Class II
- terminated
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class II recall of Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ.… by Avkare, citing 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% Pres….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1146-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-08-11 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | n/a |
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
Identifiers
| ndc | 42291-741-51 |
|---|---|
| code_info | Lot # P23025 Exp. 02/24/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1146-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.