The U.S. Food and Drug Administration (FDA) conducted an inspection at Sun Pharmaceutical Industries Limited's Halol Facility from 2 June to 13 June 2025.

The FDA has now classified the facility as "Official Action Indicated" (OAI). This means the FDA considers the facility to be not fully compliant with regard to certain current good manufacturing practices (CGMP).

The Halol facility is under Import Alert, resulting in the refusal of shipments from the facility into the US, barring certain exemptions due to drug shortage, until the facility becomes fully compliant with FDA and CGMP standards.

Sun Pharma remains committed to working with the FDA and maintaining CGMP standards at all of its facilities to provide high-quality medicines to patients globally.