Sodium Fluoride 1 — Class II drug recall D-1146-2023
Terminated recall by AVKARE LLC, reported 2023-09-13. Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.
| Recall number | D-1146-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE LLC, Pulaski, TN, United States |
| Recall initiated | 2023-08-11 |
| Classified | 2023-09-07 |
| Reported by FDA | 2023-09-13 |
| Terminated | 2024-04-29 |
| Quantity | 35,184 tubes |
| Reason classes | labeling |
| NDC | 42291-0741, 42291-0741-51 |
| Lot numbers | P23025 |
| Expiration dates | 2025-02-24 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1146-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.