User account menu Search Menu Quality Product recalls Novartis maintains a comprehensive process across the entire company to assess quality defects and safety issues and whether a market action (such as a product recall) would be required. Any such occurring incident is escalated through an established company-wide quality assurance process that enables a prompt investigation and assessment by committees consisting of subject-matter experts, quality management, medical safety experts and regulatory responsible persons. Conclusions from these committees are provided, with relevant documentation, including a safety assessment, to the competent responsible health authorities in impacted markets. Market actions, e.g., product recalls, will then be executed following an established process as agreed with and endorsed by the respective health authorities. In 2020, Novartis initiated 27 product recalls. There were no global recalls in 2020. 2016 2017 2018 2019 2020 Recalls 48 46 42 29 27 FDA recalls 1 0 0 2 2 0 Class I recalls 2 0 0 5 3 1 Class II recalls 31 32 18 21 21 [1] As recorded on the FDA’s Recalls, Market Withdrawals & Safety webpage [2] Definition of Class I/II recalls is given on the FDA webpage: Recalls Background and Definitions Related Links Product Sales Product and patient safety training Novartis production and manufacturing B-roll (Video) Novartis key multiple sclerosis product Gilenya® approved in China Novartis Navigate Topics Explore Companies Footer Bottom © 2021 Novartis AG Terms of Use Privacy Contacts Cookie Settings Site Map Novartis Site Directory This site is intended for a global audience Your privacy is important for us. We use cookies to enhance your experience when visiting our websites: performance cookies show us how you use this website, functional cookies remember your preferences and targeting cookies help us to share content relevant to you. Select “Accept all” for giving your consent to all cookies, select “Cookie settings” for managing the different cookies or select “Reject all” for using only strictly necessary cookies. You can change your cookie settings at any point of time by pressing the cookie settings link on the website. Cookie Settings Reject all Accept all