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| 1 minute read

Is your company "recall ready"? FDA's voluntary recall guidelines tell you how to be.

Companies know they need to be ready for a recall, but often don't know what steps they need to take to become "recall ready." The U.S. Food and Drug Administration ("FDA") recently issued final guidance that provides the closest thing to a step-by-step guide that I have seen to date. It explains how companies should  initiate voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the market.”

In the article accompanying this post, the lawyers at Faegre Drinker do an excellent job of summarizing those steps by focusing on the FDA's recommended answers to 4 questions: (1) How should a company in the product distribution chain prepare to facilitate timely initiation of a voluntary recall?; (2) What should a company do if there is an indication of a problem with a distributed product?; (3) How should a company initiate a voluntary recall?; and (4) How does FDA work with a recalling company to initiate a voluntary recall in a timely manner?

While the FDA's guidance document is technically non-binding on companies, it clearly represents best practices and reflects the FDA's expectations. This is a must read for any company that needs to be "recall ready."

The guidance covers voluntary recalls of food, drugs, devices, biological products, cosmetics and tobacco. It stresses the importance of being “recall ready” at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for potential recalls and implement recalls.


litigation, fda, recall