Ventura Foods Llc recalled this product and the FDA reported the enforcement action on 11 January 2023 as Class I. The recall was initiated by the firm. Tartar sauce was found to contain undeclared fish, soy, and milk allergens which was not declared on the label.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
Product
Culvers Tartar Sauce 2 oz. plastic cups
Reason for recall
Tartar sauce was found to contain undeclared fish, soy, and milk allergens which was not declared on the label.
Five things about this record are not in the record itself, and each one changes how it should be read.
Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 7 weeks, from 16 December 2022 to termination on 1 February 2023. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The FDA published the enforcement report 4 weeks after the firm began the recall.
Recalls of a sauce, dip or condiment run a median of 6 months, so this one was shorter than usual for its category. Sauces and dips sit at the intersection of the acidified foods rule and the allergen rule: an equilibrium pH above 4.6 turns a shelf-stable product into a botulism risk, and the ingredient list is long enough that an allergen is easy to lose.
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
21 CFR 117.135(c)(2)
Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
21 CFR 101.4
Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
21 CFR 117 subpart G
Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
The allergens named in this record: milk, soy, fish.
Other sauces, dips and condiments recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Undeclared Soy. Finished product ingredients statement declares Worcestershire sauce but does not declare sub-ingredients Soy Flavoring and Soy Lecithin.
Two lots of Sysco Classic Liquid Margarine have mislabeled interior packaging that identifies the product as Clear Canola Salad Oil STF which does not declare soy lecithin on the labeling.
A blue plastic bag was inadvertently introduced into product stream. During the manufacturing process, the blue plastic bag was torn into many pieces and ended up in the finished product. While many pieces of the blue plastic bag have been recovered, there is no evidence that all pieces are accounted for.
21 CFR 117.135(c)(2) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.
