Guide · the terms in every record
Recall classes, warning letters, FSVP and the COA, in plain English
The five terms that appear in almost every action on this site, defined the way a QA lead needs them, not the way the statute reads.
What is a Class I recall?
A Class I recall is FDA's most serious category: there is a reasonable probability that using the product will cause serious adverse health consequences or death. Salmonella and Listeria contamination and undeclared major allergens are almost always Class I.
Classification is assigned by FDA after the firm initiates the recall, which is why a fresh recall announcement shows no class and the enforcement record, published weeks later, does. On this site, red marks Class I.
Class I, Class II and Class III, side by side
| Class | FDA's definition, shortened | Typical reasons |
|---|---|---|
| Class I | Reasonable probability of serious health consequences or death | Salmonella, Listeria, E. coli, undeclared peanut, egg, milk, tree nut, hidden drug ingredients |
| Class II | May cause temporary or medically reversible harm; serious harm remote | Foreign material, improper pasteurization, allergen declared in the wrong words |
| Class III | Not likely to cause adverse health consequences | Nutrient label errors, minor labeling defects |
What is an FDA warning letter?
A warning letter is FDA's formal, public notice that an inspection or review found violations of the Food, Drug and Cosmetic Act. It asks for a written response within 15 working days. It is not a fine and not a court action; it is the step before those.
Two things QA teams get wrong: a warning letter is posted weeks to months after it was issued, and no firm tells its customers it received one. If your contract manufacturer got a letter, the letter is about your product and your name appears nowhere in it.
What is FSVP?
The Foreign Supplier Verification Program is the FSMA rule that makes the US importer responsible for verifying that each foreign supplier produces food to US standards. Any firm that brings food or ingredients into the US is an importer under the rule and needs a written FSVP for each supplier and each food.
In summer 2026 FDA issued more than fifteen warning letters to small importers for having no FSVP at all. Most of them, reading the letters, did not know the rule applied to them.
Why a supplier's COA is not a kill step
A certificate of analysis reports the results of tests a supplier ran on a sample. It describes that sample, in that lab, on that day. It does not prove the bag you received is free of Salmonella, and it is not a process that kills anything. Verification means your own test on receipt or a validated control at the supplier, not the certificate alone.
Eight moringa and greens powder recalls between May and September 2026 shared one failure: incoming botanical powder accepted on the supplier's paperwork. See the bulk supplier whose lot went to four manufacturers.