FDA Recalls Anticavity Toothpaste Sachets Due to Manufacturing Deviations
The FDA is recalling Maximum Security Anticavity Gel Toothpaste sachets distributed in Delaware and North Carolina due to manufacturing practice deviations at the producer facility.
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 Class II voluntary recall initiated by the manufacturer due to Current Good Manufacturing Practice deviations. No specific contamination, pathogen, or reported illness has been identified in the source; the recall is precautionary in nature.
Plain-English summary
The FDA is recalling Maximum Security Anticavity Gel Toothpaste (Sodium Fluoride 0.22%, Fresh Mint Flavor) in 0.15 oz (4.25 g) sachets due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturer, KENIL HEALTHCARE PRIVATE LIMITED.
The recalled toothpaste was distributed by Bob Barker Co. Inc. in Delaware and North Carolina. Approximately 1,559,000 sachets are affected, with multiple lot numbers: B0010 and B0017 (expiring 05/31/2026), B0028, B0029, and B0030 (expiring 06/30/2026), B0052 (expiring 07/31/2026), and B0091 (expiring 09/30/2026).
Consumers in Delaware and North Carolina who have purchased this product should stop using it. Consumers can identify affected products by checking the lot number and expiration date printed on the sachet against the list above. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Toothpaste
- Hazard
- manufacturing-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 B0010
- B0017
- Exp Date: 05/31/2026
- Lot B0028
- B0029
- B0030
- Exp Date: 06/30/2026
- Lot B0052
- Exp Date: 07/31/2026
- Lot B0091
- Exp Date: 09/30/2026
Distribution
Distributed in 2 states:
- DE
- NC
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