The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0434-2025·Announced 2025-05-28

Maximum Security Anticavity Gel Toothpaste recalled for CGMP deviations

Maximum Security Anticavity Gel Toothpaste (Sodium Fluoride 0.22%, Fresh Mint) distributed in Delaware and North Carolina is being recalled due to CGMP deviations identified by the manufacturer.

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 Class II recall with no reported illnesses or injuries. CGMP deviations represent a manufacturing-process concern rather than a known contamination or safety hazard, falling under voluntary precautionary recalls typical of Moderate severity.

Plain-English summary

Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, 1.5 OZ (43 g) tubes, manufactured by Kenil Healthcare Private Limited and distributed by Bob Barker Co. Inc. (Fuquay-Varina, NC) is being recalled. A total of 216,720 tubes are affected.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots are: B0013 (Exp Date 05/31/2026), B0018 (Exp Date 06/30/2026), B0053 and B0054 (Exp Date 07/31/2026), and B0090 through B0101 (Exp Date 09/30/2026).

The product was distributed in Delaware and North Carolina. This is a voluntary recall initiated by the manufacturer. Consumers who have purchased this product should stop using it and contact their healthcare provider if they have concerns.

The recalled product

Product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
Manufacturer
KENIL HEALTHCARE PRIVATE LIMITED
Category
Drug — Oral Care
Hazard
Affected units
216,720

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 B0013
  • Exp Date: 05/31/2026
  • Lot B0018
  • Exp Date: 06/30/2026
  • Lot B0053
  • B0054
  • Exp Date: 07/31/2026
  • Lot B0090
  • B0091
  • B0092
  • B0093
  • B0094
  • B0095
  • B0096
  • B0097
  • B0098
  • B0099
  • B0100
  • B0101
  • Exp Date: 09/30/2026

Distribution

Distributed in 2 states:

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 →

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