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 identified by the manufacturer. The recall affects toothpaste 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: FDA classified this as Class II. However, the source text explicitly states this is a voluntary recall for CGMP deviations with no reported illnesses or injuries, making it a precautionary recall without evidence of actual harm. Per the rubric, voluntary precautionary recalls fall under Moderate (score 2).
Plain-English summary
Maximum Security, Anticavity Gel Toothpaste (Sodium Fluoride 0.22%, Fresh Mint Flavor, 0.85 oz tubes) made by KENIL HEALTHCARE PRIVATE LIMITED and distributed by Bob Barker Co. Inc. in Fuquay-Varina, NC, is being recalled. The recall was initiated on April 24, 2025, due to Current Good Manufacturing Practice (CGMP) deviations.
The affected product was distributed in Delaware and North Carolina. Multiple lot numbers are included in this recall: Lots B0008, B0009, B0017 (expiration 05/31/2026); Lots B0042, B0043, B0044 (expiration 06/30/2026); Lots B0049, B0050, B0051, B0054, B0058, B0059 (expiration 07/31/2026); and Lots B0061, B0062, B0063, B0064, B0065, B0068, B0069 (expiration 08/31/2026). The product is identified by NDC 53247-132-03.
Consumers who have this toothpaste should stop using it and contact their distributor or healthcare provider with questions. This is a voluntary recall initiated by the firm.
The recalled product
- Product
- Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Oral Care / Toothpaste
- Hazard
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 (20)
- Lot B0008
- B0009
- B0017
- Exp Date: 05/31/2026
- Lot B0042
- B0043
- B0044
- Exp Date: 06/30/2026
- Lot B0049
- B0050
- B0051
- B0054
- B0058
- B0059
- Exp Date: 07/31/2026
- Lot B0061
- B0062
- B0063
- B0064
- B0065
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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