Fluoride Toothpaste Recalled for Current Good Manufacturing Practice Deviations
The FDA is recalling 616,160 tubes of Nature Mint Fluoride Toothpaste distributed in Delaware and North Carolina due to manufacturing practice deviations. The recall was voluntarily initiated by the manufacturer.
What this means for you
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 voluntary recall for manufacturing practice deviations with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls without reported incidents are classified as Moderate.
Plain-English summary
Nature Mint Anticavity Fluoride Toothpaste, a 0.85 oz (24 gram) tube containing sodium monofluorophosphate 0.76%, is being recalled by the FDA. Approximately 616,160 tubes were distributed in Delaware and North Carolina. The product is manufactured by KENIL HEALTHCARE PRIVATE LIMITED (made in India) and distributed by Bob Barker Co. Inc. in Fuquay-Varina, North Carolina.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. 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 product is identified by NDC 53247-131-03.
The recall was voluntarily initiated by the manufacturer on April 24, 2025, and was terminated on February 19, 2026. Consumers with affected products should stop using them and contact their supplier for replacement or refund.
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
- Hazard
- manufacturing-defect
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
Distributed in 2 states:
- DE
- NC
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