5 ounce containers of SUGAR FREE Milk Chocolate Caramels. The 5 oz container is a…
Kilwin's Quality Confections, Inc. recalled this product and the FDA reported the enforcement action on 9 September 2015 as Class II. The recall was initiated by the firm. Kilwins Quality Confections, Inc., is recalling 5 ounce containers of SUGAR FREE Milk Chocolate Caramels because they were incorrectly labeled and may contain undeclared cashew. People who have an allergy or severe sensitivity to cashew run the risk of serious or life-threatening allergic reaction if they consume these incorrectly labeled products.
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
- 5 ounce containers of SUGAR FREE Milk Chocolate Caramels. The 5 oz container is a cardboard box with clear plastic window on the front. Retail packages are packed 4 per shipping case.
- Reason for recall
- Kilwins Quality Confections, Inc., is recalling 5 ounce containers of SUGAR FREE Milk Chocolate Caramels because they were incorrectly labeled and may contain undeclared cashew. People who have an allergy or severe sensitivity to cashew run the risk of serious or life-threatening allergic reaction if they consume these incorrectly labeled products.
- Recalling firm
- Kilwin's Quality Confections, Inc.
- Firm location
- Petoskey, Michigan, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-3074-2015
- Quantity
- 300 retail units
- Distribution
- The mislabeled 5 ounce containers of SUGAR FREE Milk Chocolate Caramels were distributed by Kilwins Quality Confections, Inc., to some Kilwins retail stores located in the following states: Michigan, North Carolina, Florida, South Carolina, Pennsylvania, Wisconsin, Tennessee, Georgia, New Hampshire, New York, and Missouri, and Maryland. No international
- Initiated
- 30 July 2015
- Reported by FDA
- 9 September 2015
- Terminated
- 19 January 2016
- Firm notified by
- Telephone
- Product codes
- batch code of 82461 located on the back side of the package above the bar code
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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 6 months, from 30 July 2015 to termination on 19 January 2016. 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 6 weeks after the firm began the recall.
- Recalls of milk or a dairy product run a median of 7 months, so this one was about typical for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.
What this recall was for
Undeclared allergens
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, tree nuts.
Filed under milk and dairy and snacks and confectionery. A product can sit in more than one.
Other milk and dairy 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.
Other records from Kilwin's Quality Confections, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2025-07-23 | Kilwin's Truffle Assortment 9.5oz UPC 0 004574 0 Kilwin's Truffle Assortment 8oz UPC 0 043109 5 Kilwin's Truffle Assortment 4.75oz UPC 0 044121 8 | Kilwin's Quality Confections, Inc. | undeclared pecans | Class I |
| 2025-07-23 | Kilwin's Family Assortment 9oz UPC 0 004564 3 Kilwin's Family Assortment 14oz UPC 0 004565 0 Kilwin's Family Assortment 28oz UPC 0 004566 7 Kilwin's Family Assortment 42oz UPC 0 004567 4 | Kilwin's Quality Confections, Inc. | undeclared pecans | Class I |
| 2025-07-23 | Kilwin's Mocha Truffle bulk 2.5lbs Kilwin's Mocha Truffles 4.75oz UPC 0 043110 5 | Kilwin's Quality Confections, Inc. | undeclared pecans | Class I |
| 2012-10-24 | Kilwins Sugar Free S/F PEANUT BUTTER FUDGE, Nt. Wt. 7-oz (198 g) | Kilwin's Quality Confections, Inc. | The peanut butter ingredient used to make the product is associated with the Sunland, Inc. recall and has the potential to be contaminated with Salmonella. | Class I |
All 5 records for Kilwin's Quality Confections, Inc.
All 2015 recalls · All FDA food recall data
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.
Early accessRecall 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.