Nature Mint Anticavity Fluoride Toothpaste Recall CGMP Deviations
Nature Mint Anticavity Fluoride Toothpaste (0.76% sodium monofluorophosphate, 2.75 OZ tube) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots were 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: The source identifies this as an FDA Class II recall for CGMP deviations. No reported illnesses, injuries, or confirmed contamination is stated in the source text; this is a precautionary recall based on manufacturing deviations. Per the rubric, Class II without reported illness hospitalization is scored as 2 (Moderate).
Plain-English summary
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, made in India and distributed by Bob Barker Co. Inc. in Fuquay-Varina, NC. The product is identified by NDC 53247-131-05. Approximately 160,848 tubes are affected.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process. This is a voluntary recall initiated by the firm.
The affected product lots are: B0032, B0047, B0048, B0055, and B0056 (expiration date 07/31/2026); and B0102, B0103, B0104, B0105, B0106, and B0107 (expiration date 09/30/2026). The product was distributed in Delaware and North Carolina.
Consumers who have purchased this product should stop using it and contact Bob Barker Co. Inc. for instructions on return or disposal. Healthcare providers and consumers with questions may contact the FDA or the recalling firm.
The recalled product
- Product
- Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Toothpaste / Oral Care
- Hazard
- Affected units
- 160,848
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 (13)
- Lot B0032
- B0047
- B0048
- B0055
- B0056
- Exp Date: 07/31/2026
- B0102
- B0103
- B0104
- B0105
- B0106
- B0107
- 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.
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