According to the FDA’s Inspection Operations Manual 2024, a recall is defined as “the removal or correction by a company of a marketed product that FDA determines to be in violation of laws under its jurisdiction and may initiate legal action (e.g., seizure).”
Recalls are classified by the FDA into one of three options:
Class I Recall
“A Class I recall refers to a situation in which there is a substantial likelihood that serious health injury or death will occur as a result of use of or exposure to the violative product.”
Class II Recall
“A Class II recall is a situation in which use of or exposure to a violative product may result in temporary or medically reversible adverse health effects or is unlikely to result in serious adverse health effects.”
Class III Recall
“Class III recalls refer to situations where adverse health effects are unlikely to result from use of or exposure to the violative product.”
Federal law requires that a “task committee of Food and Drug Administration scientists” determine the classification of a recall based on the risk and consequences of the issue. Although recall classifications seem clearly defined, in practice the FDA seems to classify recalls in any way that suits its needs and desires. For example…
In the FDA Enforcement Reporting Record (Veterinary Category) for the week of June 19, 2024, there are two reports of pet foods recalled for the same reason: “potential metal contamination.”
The reason for both recalls is “metal contamination.” However, the pet food recalls are categorized very differently.
One of the pet foods is Pedigree dog food, a product of Mars Petcare Inc. The reason for the recall listed in the enforcement report is “potential metal contamination.” FDA scientists have classified the pet food recall as Class II, “unlikely to pose serious health risks.”
The other pet food is a raw pet food, TDBBS Green Tripe product. The reason for this recall is also “foreign body (metal) contamination” as stated in the enforcement report. However, FDA scientists classified this pet food recall as a Class I recall, which means “the violative product poses serious health risks or death.”
The same recall cause is classified in very different ways. Why did FDA scientists classify the metal contamination in these two pet foods differently? Perhaps the FDA classified them differently depending on who the manufacturer is and what is required for a Class I recall.
The big difference between a Class I and Class II recall is the public press release, which is only required for Class I cases.
In other words, a recall press release was required to be issued because the metal contamination in the raw pet food was classified as Class I. However, because the FDA classified the metal contamination recall in Pedigree dog food as Class II, Mars Petcare did not have to announce to the public that it was recalling the dog food.
The TDBBS recall notice was released to the press directly by the FDA, but because the Mars Petcare Pedigree recall was a Class II recall, Mars Petcare was able to keep the recall secret (for the same reasons).
If pet owners want to keep track of these special/unannounced recalls, the easiest way to see what’s happening in the industry is to check the Enforcement Report records. These FDA records are updated weekly.
Please visit this FDA page: https://www.accessdata.fda.gov/scripts/ires/index.cfm
This FDA page allows you to open monthly records and then specific week records within each month. To narrow the results to only pet products, after opening a specific week record, select the “Veterinary” option under product type.
I wish you and your pet all the best.
Susan Thixton
Pet Food Safety Advocate
The Truth About Pet Food
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