Quality & complianceOfficial

FDA classifies Pritam International drug recall as Class II over CGMP deviations

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

A nationwide US recall involving Pritam International Private Limited, listed under number D-0069-2027, has been classified Class II for current good manufacturing practice deviations and remains ongoing.

The US Food and Drug Administration has published a Class II drug recall in its enforcement report dated 28 October 2026. The recalling firm is Pritam International Private Limited, and the entry is titled "ARU".

The reason given for the recall is CGMP deviations, meaning departures from current good manufacturing practice. The recall carries the number D-0069-2027 and its status is listed as ongoing.

The distribution is described as US nationwide. The material available to VigiEye does not include the product description, strengths, lot numbers, quantities, event ID or details of the specific deviations, so the scope of affected product cannot be assessed from this entry alone.

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

What it means for your team

  • Supply chain and quality teams with ties to Pritam International should check the full FDA enforcement report record for product and lot details under recall number D-0069-2027.
  • Because the recall is ongoing and nationwide in the US, distributors and wholesalers may need to verify whether they hold affected stock.
  • Quality assurance teams may wish to review supplier qualification and audit files where a CGMP-related recall involves a contract or sourcing partner.

Official source: FDA enforcement report ↗

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

More Quality & compliance All →