FDA Issues Final Guidance for Voluntary Recalls

March 7, 2022—The FDA recently announced it has finalized guidance to help companies prepare to quickly and effectively remove violative products from the market.

According to the FDA, the guidance describes steps that companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning, and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public’s exposure to risk.

The final guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, explains how companies should have adequate product coding and maintain distribution records to facilitate faster, more accurate recall actions, which the FDA recommends all companies do. The FDA stated that it encourages recalling companies to use electronic communications to quickly identify and provide certain product information when alerting consignees and the public about a voluntary recall.

The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem. Because recalls can affect the entire supply chain, including downstream suppliers, wholesalers, or vendors, the FDA recommends that companies develop recall procedures to quickly inform their entire distribution chain, so consignees can rapidly identify affected lots and recall downstream products when necessary.

The FDA noted that a voluntary recall is an action taken by a company to correct a violative product or remove it from the market. A recalling company may act on its own initiative, or the FDA may inform the company that a distributed product violates the law and recommend the company recall the product. The FDA has the authority to require recalls of certain products in particular circumstances, such as controlled substances, biological products, human cells, tissues and cellular and tissue-based products, medical devices, and foods.

Judith McMeekin, PharmD, FDA Associate Commissioner of Regulatory Affairs, commented in the agency’s press release, “Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe. It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain. We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”

The FDA advised that this is the latest action reflects the agency’s ongoing commitment to work closely with companies so they can quickly act to protect the public from violative products on the market.

In recent years, the FDA has made proactive and systemic improvements to recall processes, including issuing guidance on public availability of lists of retail consignees to effectuate certain human and animal food recalls (here, November 2020); mandatory recalls for human and animal foods (here, November 2018); and public warnings and notifications for all FDA-regulated products (here, February 2019, which reiterates a policy to rapidly post new recalls to the FDA’s weekly Enforcement Reports, a public listing of all recalls monitored by the FDA.