The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0433-2025·Announced 2025-05-28

Maximum Security Anticavity Toothpaste Sachets Recalled for CGMP Deviations

KENIL HEALTHCARE PRIVATE LIMITED is recalling Maximum Security Anticavity Gel Toothpaste sachets distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.

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: The recall is FDA Class II with no reported illnesses or injuries. CGMP deviations are manufacturing-process defects rather than known contamination or high-risk pathogens, falling within the Moderate category as a precautionary manufacturing-compliance issue.

Plain-English summary

Maximum Security Anticavity Gel Toothpaste (Sodium Fluoride 0.22%, Fresh Mint Flavor, 0.15 oz sachets, NDC 53247-132-01) manufactured by KENIL HEALTHCARE PRIVATE LIMITED and distributed by Bob Barker Co. Inc. is being recalled. The recall affects approximately 1,559,000 sachets with specific lot numbers and expiration dates: Lot B0010 and B0017 (Exp. 05/31/2026); Lot B0028, B0029, and B0030 (Exp. 06/30/2026); Lot B0052 (Exp. 07/31/2026); and Lot B0091 (Exp. 09/30/2026).

The recall was initiated by the manufacturer on April 24, 2025, and classified by the FDA on May 19, 2025, as a Class II recall. The reason for recall is Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in Delaware and North Carolina.

This is a voluntary recall initiated by the firm. Consumers who have this toothpaste should discontinue use and dispose of it safely. The recall was terminated on February 19, 2026.

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 / Oral Care
Hazard
Affected units
1,559,000

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:

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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