Nature Mint Anticavity Fluoride Toothpaste Recall Due to Manufacturing Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (0.85 oz tubes) 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 for CGMP deviations with no reported illnesses or injuries. The source text does not indicate hospitalization reports or actual harm, making this a precautionary recall based on manufacturing process deficiencies rather than a demonstrated safety hazard.
Plain-English summary
KENIL HEALTHCARE PRIVATE LIMITED is recalling 616,160 tubes of Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams). The product is manufactured in India and distributed by Bob Barker Co. Inc., Fuquay-Varina, NC. The affected lots are B0014, B0015, B0022, B0023 (expiring 05/31/2026); B0024, B0025, B0026, B0027, B0033, B0034, B0035, B0039, B0040, B0041, B0045 (expiring 06/30/2026); and B0046 (expiring 07/31/2026).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The product has been distributed in Delaware and North Carolina. This is a voluntary recall initiated by the firm.
Consumers who have purchased this toothpaste should stop using it. Consumers with questions may contact their pharmacy or the product distributor for further information. The FDA classified this as a Class II recall on May 19, 2025, and the recall was terminated on February 19, 2026.
The recalled product
- Product
- Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Oral Care / Toothpaste
- Affected units
- 616,160
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 (19)
- Lot B0014
- B0015
- B0022
- B0023
- Exp Date: 05/31/2026
- Lot B0024
- B0025
- B0026
- B0027
- B0033
- B0034
- B0035
- B0039
- B0040
- B0041
- B0045
- Exp Date: 06/30/2026
- Lot B0046
- Exp Date: 07/31/2026
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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