FDA utilizes a variety of regulatory tools, including voluntary recalls, to protect consumers from and inform consumers about distributed products that violate FDA regulations. With voluntary recalls, the company takes action by correcting a violative product in commerce (correction) or removing it from the market. Voluntary recalls are generally more efficient than pursuit of regulatory enforcement strategies, such as a mandatory recall, seizure, or injunction.

When a firm finds that it has distributed a product that is adulterated or misbranded, it is the firm's responsibility to notify direct downstream customers of the situation, so that the product is corrected or promptly removed from the market. Additionally, when a product distributed at the consumer level may pose serious adverse health consequences or death to humans or animals, such as a product containing an undeclared allergen, or when use of or exposure to a violative product may cause temporary or medically reversible adverse health, FDA expects that a recalling firm will issue a public warning, in the form of a press release, to alert the public of the recall event and the dangers of using or consuming the product. These notifications are published via FDA's website² and they are often shared via the Agency's social media channels, including Twitter.³ If a company refuses to issue a public warning, and the product poses a serious hazard to health, then FDA will likely prepare and post an advisory to the FDA website.

In addition to a public warning, every removal and correction that has been determined to be a recall by FDA is shared with the public via the FDA's Enforcement Report.⁴ This is pursuant to Part 7 of 21 Code of Federal Regulations,⁵ which states that FDA will promptly make available to the public in the weekly FDA Enforcement Report a descriptive listing of each new recall according to its classification, whether it was FDA-requested or firm-initiated, and the specific action being taken by the recalling firm. 

As part of FDA's continued commitment to protect, promote, and advance public health, as well as enhance public awareness of recalls, FDA has created the Enforcement Report Subscription Service.¹ Initially released in April 2021, the Enforcement Report Subscription Service enables consumers and industry to sign up for e-mail notifications of new and updated recalls that are posted to the Enforcement Report webpage. Subscribers can choose to be notified of a specific recall event or commodity-specific recalls, such as food, drugs, and/or medical devices, on a daily or weekly basis.

Previously, interested individuals would need to proactively visit the Enforcement Report and review. This new subscription service makes the Enforcement Report more powerful for users, enabling them to tailor the content they receive to their interests. The agency encourages food processors and consumers to subscribe now to receive notifications on items of interest and/or business.

References

1. U.S. Food and Drug Administration (FDA). "Enforcement Report: FDA Recall Information Search: Email Updates." July 2022. https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=subscription.login.
2. FDA. "Recalls, Market Withdrawals, & Safety Alerts." September 22, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.
3. 3 FDA. "U.S. FDA Recalls." Twitter. https://twitter.com/FDArecalls.
4. 4 FDA. "Enforcement Reports." September 18, 2019. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports.
5. 5 Code of Federal Regulations. 21 C.F.R. § 7.40 Subpart C. "Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities." June 16, 1978. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-C.