Class IIOngoing · reported 2020-11-04

Happy Tot Superfoods Gluten Free Oat Bar Organic Bananas, Strawberries, & Sunflower…

Nurture Inc. dba Happy Family recalled this product and the FDA reported the enforcement action on 4 November 2020 as Class II. The recall was initiated by the firm. Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

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
Happy Tot Superfoods Gluten Free Oat Bar Organic Bananas, Strawberries, & Sunflower Butter. SKU: TB-BASTSB-5 and TB-BASTSB-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125g). UPC code: 819573015089.
Reason for recall
Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
Firm location
New York, New York, United States
Classification
Class II
Status
Ongoing
Recall number
F-0068-2021
Quantity
18,196 cases
Distribution
AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VI, WA, and WI. International consignees: Bermuda, Cambodia, South Africa, South Korea, Trinidad, and Tobago.
Initiated
12 October 2020
Reported by FDA
4 November 2020
Firm notified by
Letter
Product codes
BB 13 APR 2021 20104 BB 08 MAY 2021 20129 BB 20 MAY 2021 20141 BB 21 MAY 2021 20142 BB 08 JUN 2021 20160 BB 09 JUN 2021 20161 BB 15 JUN 2021 20167

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 is one of 3 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 3 separate recalls, which almost every published figure does, overstates it by a factor of 3. All 3 of them are listed on this page.
  • This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
  • The distribution pattern names 39 states, and the FDA published the enforcement report 3 weeks after the firm began the recall.
  • Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.

Named in the distribution pattern: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, U.S. Virgin Islands, Washington. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

What this recall was for

Spoilage and mould

A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.

A preventive controls plan covers spoilage 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 117.93
Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
21 CFR 117.80(b)(3)
Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.

Filed under infant formula and baby food, milk and dairy, fresh produce, snacks and confectionery and grains, flour and pasta. A product can sit in more than one.

Every product in this recall

The FDA opened 3 enforcement records for this one recall, one per product code. This page carries all of them; the 2 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

Other infant formula and baby food 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.

ReportedProductFirmReasonClass
2022-02-09Kirkland Signature Organic Soy Non-Dairy Beverage Vanilla; 12- 32 oz. cartons (note- 12 count consumer display case) SunOpta Item number 1243803 Individual Carton UPC: 0 96619 99861 6; 12 x 32 oz. container carton UPC: 096619 49000 4 Ambient, keep refrigerated after opening. Best if used within 7 10 days after opening, not to be used as infant formula. Distributed by: Costco Wholesale Corporation P.O. Box 34535 Seattle, WA 98124SunOpta Grains and Foods Inc.Product that did not meet quality standards was released in error. Complaints of spoilage received.Class II
2020-11-04Happy Kid Gluten Free Fruit & Oat Bar Organic Blueberry & Raspberry. SKU: KB-BLRB-5. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.99 oz(28g) and packed in 5 pack box (Net Wt. 4.95 OZ (140g). UPC code: 819573014389.Nurture Inc. dba Happy FamilyRecall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).Class II
2020-11-04Happy Tot Superfoods Gluten Free Oat Bar Organic Blueberries & Oatmeal. SKU: TB-BLOT-5 and TB-BLOT-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125g). UPC code: 819573015072.Nurture Inc. dba Happy FamilyRecall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).Class II
2014-08-06HyVee applesauce; 3.5 oz applesauce in aluminum pouch with plastic screw-on lid; product is labeled in part, "***HyVee Mother's Choice Apple organic baby food NET WT 3.5 OZ (99g)***INGREDIENTS:ORGANIC APPLE, ASCORBIC ACID DISTRIBUTED BY HY-VEE, INC WEST DES MOINES, IA 50266 PRODUCT OF CHILE***" UPC Code: 075450082029PUREFRUIT CHILE S.APurefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.Class II

Other records from Nurture Inc. dba Happy Family

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

All 3 records for Nurture Inc. dba Happy Family

All 2020 recalls · All FDA food recall data

21 CFR 117.93 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.