Quality & complianceOfficial

FDA lists Class II recall of Brush Buddies cavity protection product over CGMP deviations

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

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

The US Food and Drug Administration has entered a Class II drug recall for BB (Brush Buddies) Cavity Protection in its enforcement report dated 28 October 2026. The recalling firm is Pritam International Private Limited.

The recall carries the number D-0066-2027 and the stated reason is CGMP deviations, meaning departures from current good manufacturing practice. The status is listed as ongoing, and distribution is described as US nationwide.

The text available for this item is limited to the database record header and search-page content. It does not give details of the specific deviations, the product strengths or formats, lot numbers, quantities, or the date the recall began. Those points cannot be confirmed here.

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

What it means for your team

  • Quality teams should treat the CGMP-deviation reason as a prompt to check supplier and contract-manufacturer audit findings for any link to the named firm.
  • Distributors and retailers handling oral-care or cavity-protection products in the US should check the full FDA enforcement report entry for D-0066-2027 for lot and code details.
  • Regulatory teams should track the recall's ongoing status, as the public record gives no information on scope or closure.

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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