Finished Dosage Form Drug Products, Active Pharmaceutical Ingredients, and Inactive Ingredients for Potentially Hazardous Microbiological Contamination

Why FDA issued it

NOTE: The revision of this Import Alert, dated 05/05/2026, updates the alert to include updated Guidance standard language and Agency contacts. Changes are bracketed by asterisks (***). FDA collects and analyzes samples of finished dosage form drug products, active pharmaceutical ingredients (APIs), and inactive ingredients considered at risk for potentially hazardous microbial contamination that pose a health risk. Detention without physical examination may be appropriate when sample results reveal a potential health risk.

Quoted from the “Reason for Alert” section of the FDA page for 55-05, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.