CLASS II Drug recall · Reported 28 May 2025 · FDA Enforcement Report
Maximum Security, Anticavity Gel Toothpaste recalled
Kenil Healthcare Private is recalling Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 22%, Fresh Mint Flavor, distributed in Delaware, North Carolina. The recall was initiated on 24 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0433-2025
- FDA event ID
- 96797
- Recalling firm
- Kenil Healthcare Private, Ta. Kadi, District Mehsana, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2025
- FDA classified
- 19 May 2025
- Reported
- 28 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 24 Apr 2025 | Recall initiated by company | |
| 19 May 2025 | Classified by FDA | +25 days |
| 28 May 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
DE and NC
Questions about this recall
Is Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 22%, Fresh Mint Flavor recalled?
Yes. Kenil Healthcare Private recalled Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 22%, Fresh Mint Flavor on 24 Apr 2025. The recall is Class II and its status is Terminated. Recall number D-0433-2025.
Why was it recalled?
CGMP Deviations
Which lots are affected?
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 was it sold?
DE and NC
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.