Must a quality related return, at the request of the API manufacturing site, from another site within the same company be recorded as a ‘recall’?

No, provided that no portion of the batch left direct control of the company for sale or use. It must be clearly visible in the API site’s Quality System as a return triggered by the API manufacturing site so this is clear in quality system trend reporting and in the Product Quality Review [ICH Q7, Sections 2.50, 15.13; and 15.14].