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Glossary of Terms Related to Food Recalls
RECALL CLASSIFICATIONS
Class I Recall
The FDA's highest-risk recall classification.
A Class I situation exists when there is a reasonable probability that using or being exposed to the product could cause serious adverse health consequences or death.
Examples can include dangerous pathogens, serious undeclared allergens or other hazards capable of causing severe injury or illness.
Important: Class I describes the potential health hazard, not how many people have actually become sick.
Class II Recall
A recall in which the product may cause temporary or medically reversible health effects, or where the probability of serious health consequences is considered remote.
Class II does not mean “harmless.” It means FDA considers the expected risk lower than a Class I situation.
Class III Recall
A recall involving a product that is not likely to cause adverse health consequences, although it still violates FDA requirements.
These recalls may involve labeling, packaging or manufacturing problems that do not ordinarily pose a meaningful health threat.
Not Yet Classified
The company has initiated a recall, but FDA has not finished evaluating the health risk and assigning Class I, II or III.
A recall can therefore be real and active before a classification appears in FDA's Enforcement Report.
On-Going
The recall is currently in progress.
Products may still be moving through the recall process, being located, returned, destroyed or otherwise accounted for.
Completed
The company has recovered or corrected the product that could reasonably be expected to be recovered.
But here's the wrinkle: Completed does not mean FDA has formally terminated the recall.
Terminated
FDA has reviewed the recall and determined that reasonable efforts have been made to remove or correct the affected product and that proper disposition has occurred.
In other words:
On-Going → work still underway
Completed → company recovery/correction work essentially finished
Terminated → FDA has formally closed the recall
FDA specifically notes that recalls not marked “terminated” may be either ongoing or completed.
Recall status
Types of Product Removal
Recall
Removal or correction of a marketed product that FDA considers to violate the laws it administers and against which the agency could take legal action.
Most recalls are initiated voluntarily by companies.
Voluntary Recall
A company removes or corrects a product on its own initiative or after FDA requests that it do so.
“Voluntary” does not mean the problem is minor. Many serious Class I recalls are voluntary.
FDA-Requested Recall
FDA asks a company to recall a product after determining that a recall is warranted.
The company may then conduct the recall voluntarily in response to FDA's request.
Mandatory Recall
A recall ordered under statutory authority rather than initiated voluntarily.
For certain foods, the Food Safety Modernization Act gives FDA mandatory recall authority when specific conditions involving serious health risks are met and the responsible company does not voluntarily act.
Market Withdrawal
A company removes or corrects a product involving a minor violation that ordinarily would not result in FDA legal action.
A market withdrawal is not the same thing as an FDA recall.
Stock Recovery
Removal or correction of a product that has not yet entered the marketplace or left the manufacturer's direct control.
Because consumers never received it, a stock recovery is not considered a recall.
Dates and Identification
Recall Initiation Date
The date the company first began notifying the public or its customers/distributors about the recall.
This can be earlier than the date FDA publishes the recall.
Center Classification Date
The date FDA officially assigned the recall its Class I, II or III classification.
Recall Number
An FDA-assigned alphanumeric identifier used to track a specific recalled product.
Example:
H-0767-2026
Event ID
An FDA tracking number assigned to the overall recall event.
One recall event can sometimes contain more than one recalled product or recall number.
Code Information
The identifying information consumers need to determine whether their particular product is affected.
This can include:
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Lot or batch numbers
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UPCs
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Product numbers
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Expiration dates
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Best-by dates
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Use-by dates
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Serial numbers
Distribution Pattern
The states, countries, territories or other areas where the product was initially distributed.
FDA cautions that later redistribution by wholesalers or other recipients may not always be reflected in the original distribution pattern.
People and Companies Involved
Recalling Firm
The company that initiates the recall.
This may be the manufacturer, distributor or company primarily responsible for marketing the product.
The brand name consumers recognize is not always the same as the recalling firm.
Consignee
A business or organization that received the affected product.
Depending on the supply chain, a consignee might be a distributor, wholesaler, retailer, hospital, restaurant or another business.
How a Recall is Managed
Recall Strategy
The plan for carrying out a recall.
FDA evaluates issues including how far through the distribution chain the recall should extend, whether a public warning is necessary and how the company will verify that recipients responded appropriately.
Depth of Recall
How far down the supply chain the recall must reach.
FDA generally describes three levels:
Consumer/User Level: reaches the person who purchased or uses the product.
Retail Level: reaches stores and other retailers.
Wholesale Level: reaches wholesalers and distributors.
Effectiveness Check
A check used to determine whether businesses or consumers who should have received recall information actually received it and took the appropriate action.
Public Warning
A public notice used when a recalled product presents a sufficiently serious health hazard and additional public notification is needed to prevent its use.
FDA Reporting Terms
Enforcement Report
FDA's searchable record of recalls it monitors.
The Enforcement Report contains Class I, Class II, Class III and some Not Yet Classified recalls.
It can contain recall information that never appeared as a widely circulated FDA press release.
HHE — Health Hazard Evaluation
An FDA risk evaluation used in determining the health hazard associated with a defective product and helping determine the appropriate recall classification and response.
RFR — Reportable Food Registry
An FDA electronic reporting system used by food-industry facilities when there is a reasonable probability that a food will cause serious adverse health consequences or death.
The RFR applies to FDA-regulated human and animal foods, with certain exceptions including dietary supplements and infant formula.
FDA — Food and Drug Administration
The federal agency responsible for regulating most foods sold in the United States, as well as drugs, medical devices and numerous other products.
FSIS — Food Safety and Inspection Service
This one is not part of FDA.
SIS is an agency within the U.S. Department of Agriculture (USDA) and oversees recalls involving most meat, poultry and processed egg products.
That is why some Maria Approved It Recall Watch articles, such as beef recalls, will cite USDA/FSIS rather than FDA.
Hazard Terms You'll Often See
Potential Contamination
Evidence indicates a contaminant may be present, but this wording does not necessarily mean every package is contaminated or that contamination has been conclusively confirmed.
Presumptive Positive
An initial test indicates that a pathogen or other target may be present, but additional testing or investigation may still be underway.
Undeclared Allergen
An allergen is present in the food but is not properly disclosed on the label.
For someone with the relevant allergy, this can create a serious or potentially life-threatening risk.
Foreign Material
An unintended physical object or substance found or potentially present in food.
The recall notice may identify the material, such as metal, plastic or glass, but sometimes FDA simply reports “foreign material” without specifying what it is.
Outbreak
A foodborne-illness outbreak and a recall are not the same thing.
A recall removes a product from commerce.
An outbreak involves illnesses linked through epidemiological, laboratory and/or traceback evidence.
A recall may occur without any reported illnesses, and an outbreak investigation may lead to multiple recalls involving several companies or products.
Product Identifiers
UPC — Universal Product Code
The barcode number used to identify a retail product.
A UPC can help identify the affected product, but consumers may also need to match the lot number or date.
Lot / Batch Number
A code identifying a particular production run.
This is often one of the most important pieces of information in a recall because a company may recall only certain production lots rather than every package bearing the brand name.
Best By / Best Before
Generally a quality-related date, not automatically a food-safety expiration date.
In a recall notice, however, it can become an important way of identifying the affected production.
Use By
A date appearing on a product that may be used by manufacturers for quality or product-management purposes.
During a recall, always follow the recall notice rather than assuming a product is safe simply because its date has not passed.
The Maria Approved It rule:
When you see a recall headline, don't stop at “Product recalled.”
Look for:
What product?
Which lot or UPC?
Why?
What FDA class?
What is the status?
Where was it distributed?
Have illnesses been reported?
And what exactly is FDA telling consumers to do?
The details determine whether the warning actually applies to what's sitting in your kitchen.
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