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FDA asks companies to be “Recall Ready” and releases guidance on how to do so

As our laws currently stand, the U.S. Food and Drug Administration can inform a company that their product violates U.S. law and recommend the product be recalled. In order to further limit the public’s exposure to risk though, the FDA is encouraging companies to adopt voluntary recalls through new guidance making them “Recall Ready”.

Companies do not have to wait for the FDA to recall a product, in fact many issue their own recalls every year. These are known as voluntary recalls. The FDA wants more companies to adopt this practice, so they’ve released new guidelines to help facilitate this. Voluntary recalls are the preferred method of recall as Judith McMeekin, Pharm. D. the Associate Commissioner of Regulatory Affairs explained when she noted that, “voluntary recalls continue to be the fastest, most effective way for a company to help correct or remove violative and potentially harmful products from the market to help keep consumers safe.”

So what steps can a company take to ensure they’re “Recall Ready”? The FDA has identified the following steps:

  1. Have adequate product coding
  2. Maintain distribution records to facilitate faster, more accurate recall actions
  3. Use electronic communications to quickly identify and provide certain product information when alerting consignees and the public about a voluntary recall

In addition to the above steps, the FDA wants companies to act quickly. Instead of trying to determine the root cause of an issue, the FDA would like companies to first issue a recall of the product(s). Then they can begin work on determining what led to the recall. The FDA would also like companies to develop procedures for informing their “entire distribution train” of the recall so the information is disseminated as quickly as possible. To read the FDA’s final guidance in its totality, companies can download the information at:

To learn more about the new guidance from the FDA, click here: