Class ITerminated · reported 2018-08-15

PARFAIT BANANA, 1.0 Pound

Whole Foods Market Group Inc. recalled this product and the FDA reported the enforcement action on 15 August 2018 as Class I. The recall was initiated by the firm. Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.

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
PARFAIT BANANA, 1.0 Pound
Reason for recall
Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.
Firm location
Rockville, Maryland, United States
Classification
Class I
Status
Terminated
Recall number
F-1750-2018
Quantity
1,872 Units
Distribution
These were made in house at Whole Foods Market locations, in the Mid Atlantic Region. No foreign accounts
Initiated
13 July 2018
Reported by FDA
15 August 2018
Terminated
3 September 2021
Firm notified by
E-Mail
Product codes
24871900000

Reading this record

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 is one of 19 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 19 separate recalls, which almost every published figure does, overstates it by a factor of 19. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 19 of them.
  • The recall ran for 3.1 years, from 13 July 2018 to termination on 3 September 2021. 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 5 weeks after the firm began the recall.
  • The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

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: soy.

Other records from Whole Foods Market Group Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 36 other records name this firm.

ReportedProductFirmReasonClass
2018-08-15CANDY DESSERT SHELL VANILLA PANIBOIS, 17 OunceWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I
2018-08-15CUPCAKE BERRY CHANTILLY MEDIUM, 4.5 OunceWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I
2018-08-15CAKE FRUIT 6IN, 28.0 Ounce CAKE FRUIT 9IN, 64.0 OunceWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I
2018-08-15CAKE BLUEBERRY LEMON 6 INWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I
2018-08-15CAKE MANGO MOUSSE 9INWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I
2018-08-15PARFAIT FRESH FRUIT , 1.0 PoundWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I
2018-08-15CAKE BERRY CHANTILLY 9INWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I
2018-08-15CAKE TOASTED ALMOND 6 IN, 29.6 Ounce CAKE TOASTED ALMOND 9IN, 64.0 OunceWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I
2018-08-15CAKE LEMON RASPBERRYWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I
2018-08-15CAKE MOUSSE MANGO 6INWhole Foods Market Group Inc.Whole Foods Market, Inc. has initiated a recall of various bakery products that was made in there Mid-Atlantic stores and sold between May 25th and July 13th which failed to declare soy flour (soy) as an ingredient.Class I

All 37 records for Whole Foods Market Group Inc.

All 2018 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 access

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.