Maximum Security Anticavity Gel Toothpaste Recalled for CGMP Deviations
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 391,680 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 deviations. The source does not report any illnesses, injuries, or hospitalizations. CGMP violations are procedural/manufacturing defects with theoretical risk; no specific product harm is documented.
Plain-English summary
Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor (0.6 oz / 17 g tubes, NDC 53247-132-02), manufactured by KENIL HEALTHCARE PRIVATE LIMITED in India and distributed by Bob Barker Co. Inc. of Fuquay-Varina, North Carolina, is being recalled due to Current Good Manufacturing Practice (CGMP) deviations.
The recall involves 391,680 tubes across multiple lots: Lot B0009 and B0017 (expiration 05/31/2026), Lot B0018, B0019, B0036, B0037, and B0038 (expiration 06/30/2026), Lot B0049 (expiration 07/31/2026), and Lot B0063 (expiration 08/31/2026). The recall was initiated by the manufacturer on April 24, 2025, and was voluntary—initiated by the firm itself.
Affected consumers in Delaware and North Carolina who have purchased this product should stop using it. Consumers with questions may contact the distributor or the FDA for further guidance.
The recalled product
- Product
- Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Oral Care / Toothpaste
- Hazard
- Affected units
- 391,680
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 B0009
- B0017
- Exp Date: 05/31/2026
- Lot B0018
- B0019
- B0036
- B0037
- B0038
- Exp Date: 06/30/2026
- Lot B0049
- Exp Date: 07/31/2026
- B0063
- Exp Date: 08/31/2026
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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