Prescription Dental Toothpaste Recalled Due to Incorrect Carton Labeling
AvKARE is recalling Sodium Fluoride 1.1% prescription dental toothpaste because cartons are labeled as Capsaicin Cream 0.025%, though the tubes are correctly labeled. Approximately 35,184 tubes have been distributed to 19 consignees.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving incorrect carton labeling with no reported illnesses or injuries. The actual product is correct and properly labeled on the tube, making this a packaging error rather than a product defect. The theoretical risk of confusion warrants recall action, but correct tube labeling mitigates potential harm.
Plain-English summary
AvKARE LLC is recalling Sodium Fluoride 1.1% prescription dental toothpaste (Lot #P23025, expiration 02/24/2025) because some cartons are labeled as Capsaicin Cream 0.025%. The tubes inside the cartons are correctly labeled as Sodium Fluoride 1.1% prescription dental toothpaste.
The affected product—35,184 tubes—was distributed to 19 consignees throughout the United States. The incorrect carton labeling could result in confusion about the product contents.
Patients and dispensers who have this product should inspect the tube label, which correctly identifies the product as Sodium Fluoride 1.1% prescription dental toothpaste. Anyone with questions should contact their pharmacy or healthcare provider.
The recalled product
- Product
- SODIUM FLOURIDE (SODIUM FLUORIDE)
- Brand
- SODIUM FLOURIDE
- Manufacturer
- AVKARE LLC
- Category
- Drug — Dental / Oral Care
- Hazard
- Affected units
- 35,184
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # P23025 Exp. 02/24/2025
UPCs (1)
- 0342291741515
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by AVKARE LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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