Capsaicin Cream 0 — Class II drug recall D-1147-2023
Terminated recall by AVKARE LLC, reported 2023-09-13. Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription
| Recall number | D-1147-2023 |
|---|---|
| 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 cartons |
| Reason classes | labeling |
| NDC | 50268-0195, 50268-0195-60 |
| Lot numbers | P22078 |
| Expiration dates | 2024-11-30 |
Product
Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478
Reason for recall
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain 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-1147-2023. 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.