Recall

A recall removes or corrects a food product already on the market because it breaks the law or could hurt people. A recall can be started by the company, requested by FDA or ordered by FDA, and FDA ranks it Class I, II or III by risk.

  • Food safety
  • Rules, recalls & traceability

Under FDA's definitions, a recall is the action a company takes to pull a product off the market or fix it. The company may act on its own, at FDA's request, or under an FDA order. FDA sorts recalls into three classes. Class I is the most serious: there is a reasonable chance the product will cause serious health problems or death. Class II covers health effects that are temporary or medically reversible, or cases where serious harm is unlikely. Class III products are not expected to cause health problems. A market withdrawal is separate and handles minor issues FDA would not take legal action on.

A quick, organized recall gets unsafe or mislabeled food out of stores and homes before more people eat it. FDA relies first on companies to recall voluntarily, but since FSMA it can order a recall when a firm declines and the food is likely adulterated or misbranded in a way that could cause serious harm or death. Each recall strategy sets how deep into the supply chain to go, whether to warn the public, and how many customers to contact to confirm the product is gone.

Key facts

Recall classes
Class I (most serious), Class II, Class III
Effectiveness check levels
Five levels, from A (100% of consignees) to E (none)
Mandatory recall authority
FSMA section 206, which created FD&C Act section 423
Mock recalls (extension advice)
At least once a year

In a bakery or commercial kitchen

  • Keep a written recall plan naming who notifies direct customers, alerts the public, checks effectiveness and handles disposal of recalled product
  • Mark every batch with a lot number, date code or both so you can recall only the affected product
  • Run a mock recall at least once a year and again after major changes in staff, products or distribution
  • Call your FDA recall coordinator early, even before every detail is gathered, so the agency can help sooner
  • Track returned and accounted-for units against units shipped, and rethink your approach if not everything is accounted for

For home and cottage bakers

  • Compare the brand, size and lot or date code in a recall notice with the products in your pantry
  • Follow the notice's instructions, which typically tell you to return the product or throw it away
  • Contact a healthcare provider if you feel sick after eating a recalled food

Related entries

Sources

Written by VanillaGoods in our own words from these sources. Last reviewed October 17, 2026.

  1. Recalls Background and Definitions, U.S. Food and Drug Administration
  2. 21 CFR 7.42: Recall strategy, Electronic Code of Federal Regulations (eCFR)
  3. Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry, U.S. Food and Drug Administration
  4. 21 CFR Part 117 Subpart C: Hazard Analysis and Risk-Based Preventive Controls, Electronic Code of Federal Regulations (eCFR)
  5. Developing a Recall Plan: A Guide for Small Food Processing Facilities (B1509), University of Georgia Cooperative Extension