Recall& Mock Recall Fact Sheet
A recall is used to remove product from distribution. It may be conducted by the operation producing the food (Voluntary Recall), at the request of the FDA (Food & Drug Administration), or under statutory authority ordered by the FDA (usually a Class I recall). A recall takes place in order to: protect consumer health; comply with existing rules and regulations; minimize the cost of a recall; or, regain and improve the company in questions reputation. Recalls are often a joint effort between independent company(s) and the FDA.
Under the FDA, there are 3 classifications[1] of recalls & examples:
- Class I recall – a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
-Cantaloupes contaminated with Listeria Monocytogenes; Spinach with E. coli 0157:H7; Allergens such as peanuts/eggs not listed on label
- Class II recall – a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
-Any Class II allergen missing from the label (ie. listing butter in the ingredients, but not declaring the allergen milk)
- Class III recall – a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
-Packaged tomatoes with lower weight than that shown on the package
A recall may occur for any number of reasons, including, but not limited to the following:
- Pathogens in food or produce (ie. E. coli 0157:H7, Listeria, Salmonella, botulinum toxin, etc…)
- Undeclared Allergens (ie. Nuts, fish, dairy, eggs, etc…)
- Temperature Abuse of Sensitive Foods (soft cheeses, raw meats, etc…)
- Mislabeled Products (improper expiration dates, missing ingredients, missing allergens,etc…)
- Potential Foreign Material found in products (plastics, particulates, chipped pieces of equipment, etc…)
The size of a recall is determined by the lot number(s) associated with the recall. Generally speaking, if the size of the lots can be kept to a reasonable* size, the recall will be just as equitable (*reasonable as determined by the product owner). For example, having to recall only 10 cases because your lot numbers were able to identify the block that was contaminated on a certain day, vs 150 cases because your traceability system only identified the date of harvest and not specifically the block.
Many businesses will conduct a mock recall annually to test its ability to trace product and determine if improvements in their traceability system are needed. A mock recall is an exercise that not only ensures your system works, but also demonstrates the efficiency of the traceback. A mock recall is conducted by calling a product buyer and asking questions about a specific product (lot/batch #), particularly with respect to how much of that product is still in inventory and how much has been sold. It is good practices to note the length of time it takes to conduct a mock recall, this will help identify if changes are needed to the system.
Harvest records, invoice logs, field maps, chemical application and planting records are examples of information that may be associated with a recall.
Date Modified: Oct 10, 2014
This information is provided by CAFF in good faith, but without warranty. It is intended as an educational resource and not as advice tailored to a specific farm operation or a substitute for actual regulations and guidance from FDA or other regulatory agencies. We will not be responsible or liable directly or indirectly for any consequences resulting from use of this document or resources identified in this document.
[1] US FDA website- accessed Oct 9, 2014 : 4:51pm