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.
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: 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
- 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 (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
Distributed in 2 states:
- DE
- NC
Related recalls
Same category
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22