Class II — Moderate Risk Severity Status: Ongoing Authority: FDA

Brush Buddies

Recalling Firm / Manufacturer: PRITAM INTERNATIONAL PRIVATE LIMITED (Haridwar, India)
FDA Recall Number: D-0065-2027
View FDA Source
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
Brush Buddies
Generic Name
Not provided by source
Active Substance(s)
Not provided by source
Administration Route
Not provided by source
National Drug Code (NDC)
Not provided by source
Total Quantity Recalled
797,868 tubes
Official Reason for Recall
Specific hazard or quality defect cited by the FDA

According to the official FDA enforcement report:

CGMP Deviations.

Full Product Description
Packaging specifications and labeling details

Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-007-07, ITEM # 999131, 8 50010 84249 3

Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
October 28, 2026
Firm Initiation Date
September 10, 2026
FDA Classification Date
Oct 19, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # LWP250032331302B, Exp Date: 02/23/2027; Lot # LWP250034892603, Exp Date: 04/07/2027; Lot # LWP250032581702, Exp Date: 04/14/2027; Lot # LWP250045162409, Exp Date: 10/17/2027; Lot # LWP250032331302A, LWP250047640511A, Exp Date: 12/20/2027; Lot # LWP250051162312B, Exp Date: 01/04/2028; Lot # LWP0054880903B, Exp Date: 04/08/2028; Lot # LWP260056333003A, Exp Date: 05/15/2028.
Distribution Information
Geographic scope of affected shipments

US Nationwide.

Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.

Official Source Provenance

Verified regulatory citation from U.S. FDA OpenFDA

Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0065-2027
Questo Retrieval Date: November 03, 2026 00:00 1793664008UTCC
View Official FDA Source

System Notice

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