Recall notices
Food recall notices in the US, EU and Australia
Short answer
- FDA Class I
- Reasonable probability of serious health effects or death 1
- US Reportable Food Registry
- Report within 24 hours 3
- US grocery chain display
- Chains with 15 or more stores, within 24 hours, kept 14 days 3
- EU business duty
- Immediately inform the competent authorities 4
- Australia recalls 2016 to 2025
- 866, average 87 a year 5
- Australia recalls 2025
- 92 5
United States: FDA recall classes
The FDA says recalls may happen on a firm's own initiative, at FDA request, or by FDA order under statutory authority 1.
| Category | FDA definition |
|---|---|
| Class I recall | Reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death 1 |
| Class II recall | May cause temporary or medically reversible effects, or serious effects are remote 1 |
| Class III recall | Not likely to cause adverse health consequences 1 |
| Market withdrawal | Minor violation not subject to FDA legal action 1 |
| Medical device safety alert | Device may present an unreasonable risk of substantial harm 1 |
United States: the Reportable Food Registry
The Food and Drug Administration Amendments Act of 2007 directed the FDA to set up the Reportable Food Registry 2. It covers all FDA regulated food and feed except dietary supplements and infant formula 2. Registered facilities that make, process, pack or hold food must report when there is a reasonable probability that a food will cause serious adverse health consequences or death to humans or animals 2.
Under 21 U.S.C. 350f(d), the responsible party must report as soon as practicable and in no case later than 24 hours after deciding the food is reportable 3. The FDA may then require further steps by a deadline it sets 3. If the portal is down, firms can call 1-888-INFO-FDA 2.
The same section requires a grocery store in a chain of 15 or more physical locations that sold the food to display the one page summary within 24 hours of its publication and keep it displayed for 14 days 3.
European Union: General Food Law
Article 19 of Regulation (EC) No 178/2002 covers food business operators 4. An operator that has reason to believe a food it handled does not meet food safety requirements must immediately start to withdraw it and inform the competent authorities 4. Where the product may have reached consumers, the operator must tell them why and, if needed, recall it from them 4. An operator must immediately inform the authorities if it believes a food it placed on the market may be injurious to human health 4.
Article 50 sets up a rapid alert system for food and feed, involving the Member States, the Commission and the European Food Safety Authority 4. Members must immediately notify the Commission of serious risks and of measures to restrict, withdraw or recall food or feed 4. Article 52 says the public should in general have access to product identification, the nature of the risk and the measure taken 4.
Australia: what the recall data shows
FSANZ coordinated 866 food recalls from 1 January 2016 to 31 December 2025, an average of 87 a year 5. From 2021 to 2025, 61% were consumer recalls only, 13% trade recalls and 26% both 5. Undeclared allergens and microbial contamination were the most common reasons 5.
| Cause, 2021 to 2025 | Recalls | Leading detail |
|---|---|---|
| Undeclared allergens | 197 5 | Milk, wheat or gluten and tree nuts most common 5 |
| Microbial contamination | 91 5 | Listeria monocytogenes in 36 recalls 5 |
| Foreign matter | 60 5 | Plastic in 19 recalls 5 |
| Chemical and other contaminants | 20 5 | Ethylene oxide and thebaine, 7 each 5 |
| Biotoxins | 14 5 | Patulin, histamine, marine toxins and aflatoxins, 2 each 5 |
Allergen recalls in Australia by year
FSANZ reports 54 undeclared allergen recalls in 2024, 57% of that year's recalls, and 35 in 2025, 38% 5. The most common root cause from 2021 to 2025 was errors during packaging 5. Staff training was the most reported corrective action at 18% 5. FSANZ notes that most recalls are precautionary and only a small number are linked to reported illness or injury 5.
Common questions
What is a Class I food recall?
A recall where there is a reasonable probability the product will cause serious adverse health consequences or death 1.
How fast must US food facilities report a dangerous food?
As soon as practicable and no later than 24 hours after deciding it is a reportable food 3.
Who must tell EU authorities about unsafe food?
The food business operator, immediately, if it believes a food it placed on the market may be injurious to health 4.
How many food recalls are there in Australia each year?
FSANZ coordinated 92 in 2025 and averaged 87 a year from 2016 to 2025 5.
What is the most common reason for food recalls in Australia?
Undeclared allergens, with 197 recalls from 2021 to 2025 5.
Rules and charges change. Check the official source linked on this page before you pay or travel. Spotted an error? Email hello@noticeofrecord.com.
Sources
- FDA: Recalls Background and Definitions (content current as of 20 March 2026)
- FDA: Reportable Food Registry for Industry
- Legal Information Institute: 21 U.S. Code 350f, Reportable food registry
- EUR-Lex: Regulation (EC) No 178/2002 (General Food Law)
- FSANZ: Australian food recall statistics (page last updated 30 April 2026)
Related
- Product recall notices compared
How recall notices work at the US CPSC, FDA and NHTSA, UK OPSS, EU Safety Gate, Australia's ACCC and Health Canada, and where each list is published.
- Product safety recall notices in the European Union
What the EU General Product Safety Regulation requires in a recall notice, how the Safety Business Gateway works and what Safety Gate recorded in 2025.
- FDA warning letters explained
What an FDA warning letter is, how it differs from a Form 483 and an untitled letter, response times, close-out letters and where letters are posted.
- Product safety reporting duties compared
When businesses must tell a regulator about a dangerous consumer product or an injury: CPSC, EU GPSR, UK GPSR 2005, Canada CCPSA and the ACCC.