Product recall Class I

Recalls are an effective method for removing or correcting marketed products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA).

The FDA recall classifications range from Class I (most severe) to Class II (moderately severe) and Class III (least severe).

Class I recall is the situation in which there is reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequence or death.

Examples: Product tampering or mislabeling of a lifesaving drug; foods that are found to contain the toxin causing botulism, foods contaminated with very pathogenic pathogens (including but not limited to Listeria monocytogenes, Salmonella or pathogenic E. coli); or a food that contains one of the eight (the Big‐8) common allergens but is not properly labeled to indicate the presence of these allergens.
Product recall Class I