FDA Recalls Nature Mint Fluoride Toothpaste Due to Manufacturing Deviations
Nature Mint Anticavity Fluoride Toothpaste is being recalled by the FDA for manufacturing quality violations (CGMP deviations). The voluntary recall affects 150,768 tubes distributed in Delaware and North Carolina.
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 a Class II voluntary recall for manufacturing process deviations (CGMP violation) with no reported illnesses or injuries. The recall was terminated in February 2026, indicating resolution of the quality control issue.
Plain-English summary
Nature Mint Anticavity Fluoride Toothpaste (1.5 oz tubes, sodium monofluorophosphate 0.76%) is being recalled by the FDA. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations at the manufacturer, KENIL HEALTHCARE PRIVATE LIMITED. The product is manufactured in India and distributed in the United States by Bob Barker Co. Inc.
The recall affects 150,768 tubes with the following lot codes and expiration dates: Lot B0004 (expires 05/31/2026), Lot B0060 (expires 07/31/2026), Lots B0067, B0071, B0072 (expire 08/31/2026), and Lots B0107, B0108 (expire 09/30/2026). The product was distributed in Delaware and North Carolina.
This is a voluntary recall initiated by the manufacturer. The FDA classified this as a Class II recall. The recall was terminated on February 19, 2026, indicating that the manufacturing quality issues were resolved.
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
- Hazard
- cgmp-deviation
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:
- DE
- NC
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27