Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5...

FDA Recall #D-0434-2025 — Class II — April 24, 2025

Recall #D-0434-2025 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 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04

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

216,720 Tubes

Distribution

DE and NC

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated