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# Draft Voluntary Recall Guidance
- URL: https://www.fdaweb.com/draft-voluntary-recall-guidance/
- Published: 2019-04-23T12:00:00.000Z
- Updated: 2026-09-15T01:22:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Biologics, Drugs, Devices, #legacy-id-D5143931

FDA has issued a draft guidance, *Initiation of Voluntary Recalls Under 21 CFR part 7, Subpart C*, on the timely initiation of voluntary recalls of FDA-regulated products. The [document](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-08198.pdf?ref=fdaweb.com) discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication.

Commenting on the draft, FDA associate commissioner for regulatory affairs **Melinda Plaisier** [says](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636462.htm?utm%5Fcampaign=042319%5FPR%5FNew%20steps%20to%20strengthen%20the%20process%20of%20initiating%20voluntary%20recalls&utm%5Fmedium=email&utm%5Fsource=Eloqua) it includes recommendations for training, record-keeping, and procedures. “Today’s guidance reflects the latest step in the agency’s ongoing commitment to working with companies to quickly act to protect consumers from potentially dangerous products,” she says. “It builds upon 18 months of proactive and systematic improvements to FDA’s recall processes, during which the agency alerted companies of the situations where FDA would disclose certain supply chain and retail distribution information during certain human and animal food recalls….”