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The most recalled products by United States Pharmacopeia Therapeutic Category USPTC reflect the major quality issues over the past five years. The most substantial increases in the number of recalls by industry sector in FY2020 were in the No Application and NDA & ANDA (i.e., sites manufacturing for both application types) sectors. (See full report for additional details.) The average SIS of sites reporting at least one recall continues to be below the overall average SIS, highlighting the relationship between recalls and CGMP compliance . Each major recall over the last five fiscal years was associated with microbial or chemical contamination/impurities