Class IITerminated · reported 2022-07-20

Nature s Promise Organic Mango, Banana, Kale, Rice & Pineapple Baby Food, 3.5 oz (99 g)…

Fruselva America SPA recalled this product and the FDA reported the enforcement action on 20 July 2022 as Class II. The recall was initiated by the firm. Elevated levels of thallium (heavy metal)

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: Nature s Promise Organic Mango, Banana, Kale, Rice & Pineapple Baby Food, 3.5 oz (99 g), Pouch, Case pack of 12 (12 inners of 6 each). Store in a dry ventilated area. Do not expose to sunlight. Do not microwave. After opening, store in refrigerator a maximum of 48 hours. Shake well before opening.
Reason for recall: Elevated levels of thallium (heavy metal)
Recalling firm: Fruselva America SPA
Firm location: Maule, Chile
Classification: Class II
Status: Terminated
Recall number: F-1415-2022
Quantity: 2749 units
Distribution: The firm only distribute only to their stores; MA, ME, NH, NY, VT, MD, PA, WV
Initiated: 26 May 2022
Reported by FDA: 20 July 2022
Terminated: 19 July 2023
Firm notified by: Other
Product codes: BB 12 10 2022 Lot 253 08:48 165

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 14 months, from 26 May 2022 to termination on 19 July 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 distribution pattern names 8 states, and the FDA published the enforcement report 8 weeks after the firm began the recall.
Recalls of infant formula or baby food run a median of 10 months, so this one was longer than usual for its category. 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: Massachusetts, Maine, New Hampshire, New York, Vermont, Maryland, Pennsylvania, West Virginia. 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

Foreign material

A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.

A preventive controls plan covers foreign material 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 117.40: Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c): Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
21 CFR 117.150: Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.

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

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.

Reported	Product	Firm	Reason	Class
2019-07-24	Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g, with UPC: 078742022468	Perrigo Company PLC	Product may contain metal fragments.	Class II
2019-02-20	Parent's Choice Toddler Next Stage¿ Milk Drink Powder Natural Milk Flavor With Other Natural Flavors, Stage 3, 1 Year and Up, NET WT 24 OZ (1.5 LB) 680g, UPC: 0 78742 06717 9 and Little JOURNEY Toddler Next Stage MILK DRINK POWDER, NET WT I PESO NETO 24 OZ I ONZAS (1.5 LB) 680g.	PBM Nutritionals, LLC	Product may contain foreign material.	Class II

All 2022 recalls · All FDA food recall data

21 CFR 117.40 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.