Quality & complianceOfficial

FDA lists Class II recall of Brush Buddies Advanced Whitening over CGMP deviations

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

Pritam International Private Limited's BB (Brush Buddies) Advanced Whitening is subject to an ongoing nationwide US recall, classified Class II for current good manufacturing practice deviations.

The US Food and Drug Administration has published a Class II drug recall in its enforcement report dated 28 October 2026. It covers BB (Brush Buddies) Advanced Whitening, a product of Pritam International Private Limited.

The recall is numbered D-0067-2027 and the stated reason is CGMP deviations. Its status is listed as ongoing, and distribution is described as US nationwide.

The page text available to us is largely search-tool navigation and does not set out further details. It gives no product strengths, lot numbers, quantities, recall initiation date or specific description of the manufacturing deviations, so these cannot be reported here.

For context, the FDA assigns Class II to recalls where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams should note that the recall is attributed to CGMP deviations, a reminder of inspection and manufacturing-control expectations for finished-product makers and their suppliers.
  • Companies distributing or sourcing oral-care or similar products in the US may wish to check the full FDA enforcement entry for lot and product details, which are not in the text reviewed.
  • Because the recall is ongoing and nationwide, its scope and status could change; teams should monitor the FDA enforcement report for updates.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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