Nature Mint Anticavity Fluoride Toothpaste recall due to manufacturing deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (6.4 oz, Lot B0067, expiring 08/31/2026) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.
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 initiated voluntarily by the manufacturer due to CGMP deviations. No illnesses, injuries, or specific safety hazards are reported in the source text; the recall is precautionary based on manufacturing process defects.
Plain-English summary
KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste containing Sodium monofluorophosphate 0.76%, 6.4 ounces (181 grams), NDC 53247-131-07. The product was manufactured in India and distributed by Bob Barker Co. Inc. in Fuquay-Varina, North Carolina. The recall affects 4,176 boxes.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. CGMP deviations mean the product was not manufactured under the conditions required by federal regulations to ensure safety and quality.
The affected product is Lot B0067 with an expiration date of 08/31/2026. Distribution was limited to Delaware and North Carolina. The firm notified affected parties via email, fax, letter, press release, telephone, and direct visits beginning on April 24, 2025.
Consumers who have purchased this product should stop using it. Consult a healthcare provider with any questions about product safety or potential health concerns.
The recalled product
- Product
- Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Oral Care / Toothpaste
- Hazard
- Affected units
- 4,176
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 (2)
- Lot B0067
- Exp Date: 08/31/2026
Distribution
Part of a larger recall action
This product is one of 20 recalled by KENIL HEALTHCARE PRIVATE LIMITED 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.
See all 20 products in this recall →Related recalls
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