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Class II: temporary or reversible health riskTerminated

Kenil Healthcare Private Maximum Security Recall

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0

KENIL HEALTHCARE PRIVATE LIMITED · Ta. Kadi, District Mehsana, N/A

Risk level
Class II
Reported by FDA
May 28, 2025
Recall ID
D-0433-2025
Check your lot numberHow we source this data

Summary

Kenil Healthcare Private recalled Maximum Security starting Apr 24, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0433-2025 on May 28, 2025. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

DE and NC

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0433-2025
Classification
Class II
Status
Terminated
Recall initiated
Apr 24, 2025
FDA report date
May 28, 2025
Quantity
1,559,000 Sachets
Recall type
Voluntary: Firm initiated
Recalling firm
KENIL HEALTHCARE PRIVATE LIMITED

Original FDA data

Every field from FDA enforcement report D-0433-2025, exactly as published.

Show all FDA fields
City
Ta. Kadi, District Mehsana
Status
Terminated
Country
India
Event ID
96797
Address
Plot 319
Address (line 2)
Village Acharasan, Ankhol-Vamaj Road
Code information
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
Report date
May 28, 2025
Product type
Drugs
Recall number
D-0433-2025
Classification
Class II
Recalling firm
KENIL HEALTHCARE PRIVATE LIMITED
Product quantity
1,559,000 Sachets
Termination date
Feb 19, 2026
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
DE and NC
Recall initiation date
Apr 24, 2025
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 19, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0433-2025, published May 28, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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