Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 ...

FDA Recall #D-0431-2025 — Class II — April 24, 2025

Recall #D-0431-2025 Date: April 24, 2025 Classification: Class II Status: Terminated

Product Description

Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02

Reason for Recall

CGMP Deviations

Recalling Firm

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

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

391,680 Tubes

Distribution

DE and NC

Code Information

Lot B0009, B0017, Exp Date: 05/31/2026; Lot B0018, B0019, B0036, B0037, B0038, Exp Date: 06/30/2026; Lot B0049, Exp Date: 07/31/2026; B0063, Exp Date: 08/31/2026

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated