The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0439-2025·Announced 2025-05-28

Nature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations

KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to manufacturing deviations. The recall affects 150,768 tubes 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 for CGMP manufacturing deviations with no reported illnesses or injuries. Per the rubric, Class II recalls without hospitalization reports are typically Moderate (score 2).

Plain-English summary

KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste (0.76% sodium monofluorophosphate, 1.5 oz/43 gram tubes) sold under NDC 53247-131-04. The product is manufactured in India and distributed in Delaware and North Carolina by Bob Barker Co. Inc. of Fuquay-Varina, North Carolina.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots and expiration dates are: Lot B0004 (Exp Date 05/31/2026), Lot B0060 (Exp Date 07/31/2026), Lots B0067, B0071, and B0072 (Exp Date 08/31/2026), and Lots B0107 and B0108 (Exp Date 09/30/2026). Approximately 150,768 tubes are affected.

Consumers who have purchased this product should stop using it. Those with questions or concerns should contact their healthcare provider. The FDA classifies this as a Class II recall.

The recalled product

Product
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
Manufacturer
KENIL HEALTHCARE PRIVATE LIMITED
Category
Drug — Oral Care / Toothpaste
Hazard
Affected units
150,768

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 (11)

  • Lot B0004
  • Exp Date: 05/31/2026
  • B0060
  • Exp Date: 07/31/2026
  • Lot B0067
  • B0071
  • B0072
  • Exp Date: 08/31/2026
  • Lot B0107
  • B0108
  • Exp Date: 09/30/2026

Distribution

Distributed in 2 states:

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

Same manufacturer · KENIL HEALTHCARE PRIVATE LIMITED

See all →

Same hazard · cgmp deviation

See all →

Similar recalls