Quality & complianceOfficial

FDA lists Class II recall of 'evo' from Pritam International over CGMP deviations

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

The enforcement report entry, recall D-0059-2027, is ongoing and covers US nationwide distribution of a drug product from India-based Pritam International Private Limited.

The US Food and Drug Administration has added a Class II drug recall to its enforcement report, dated 28 October 2026. The product is named 'evo' and the recalling firm is Pritam International Private Limited.

The agency gives the reason for recall as current good manufacturing practice (CGMP) deviations. The recall number is D-0059-2027, and its status is shown as ongoing.

Distribution is listed as US nationwide. The material available to us does not give the product's dosage form, strength, lot numbers, quantities or the specific manufacturing failings behind the CGMP finding.

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

What it means for your team

  • Quality and supply-chain teams should check whether 'evo' or any Pritam International Private Limited product is in their US distribution or sourcing network.
  • Lot, code and product-type details are held in the full FDA enforcement report record under D-0059-2027, so teams should consult that entry directly.
  • As the recall is ongoing, its scope or status could still change, so teams should monitor the record 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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