Nature Mint Anticavity Fluoride Toothpaste Recall Due to CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The affected toothpaste was distributed in Delaware and North Carolina.
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 with no reported illnesses or injuries. The hazard is based on manufacturing practice deviations rather than a confirmed contamination or high-risk pathogen, making it a precautionary recall that falls under the Moderate category.
Plain-English summary
KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. A total of 498,960 tubes are affected across multiple lot numbers with expiration dates ranging from 05/31/2026 through 09/30/2026. The product was distributed by Bob Barker Co. Inc. (Fuquay-Varina, NC) in Delaware and North Carolina.
The FDA classified this as a Class II recall. Consumers who have purchased this product should stop using it and contact their retailer or Bob Barker Co. Inc. for instructions on return or disposal. Consumers with questions about the recall may contact the recalling firm through official FDA channels or the recall notification contact information provided at the time of distribution.
The recalled product
- Product
- Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Oral Care / Toothpaste
- Hazard
- Affected units
- 498,960
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 (14)
- Lot B0015
- B0016
- Exp Date: 05/31/2026
- Lot B0020
- B0021
- B0022
- Exp Date: 06/30/2026
- Lot B0056
- B0057
- Exp Date: 07/31/2026
- Lot B0108
- B0109
- B0110
- Exp Date: 09/30/2026
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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