Class IITerminated · reported 2019-02-20

Parent's Choice Toddler Next Stage¿ Milk Drink Powder Natural Milk Flavor With Other…

PBM Nutritionals, LLC recalled this product and the FDA reported the enforcement action on 20 February 2019 as Class II. The recall was mandated. Product may contain foreign material.

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: 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.
UPC: 078742067179
Reason for recall: Product may contain foreign material.
Recalling firm: PBM Nutritionals, LLC
Firm location: Milton, Vermont, United States
Classification: Class II
Status: Terminated
Recall number: F-0904-2019
Quantity: 18,632 cans
Distribution: AL AR AZ CA CO CT DE FL GA IA IL IN KS KY LA MI MN MO MS NC NH NY OH OR PA TN TX UT VA WI
Initiated: 21 January 2019
Reported by FDA: 20 February 2019
Terminated: 29 May 2019
Firm notified by: Letter
Product codes: Lot Codes: T16DTKC, T17DTJC, T20DTDC

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.
This recall was not recorded as firm-initiated. The circumstances in which the FDA requests a recall 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 4 months, from 21 January 2019 to termination on 29 May 2019. 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 infant formula or baby food run a median of 10 months, so this one was shorter 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.

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, milk and dairy and beverages and juice. 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
2022-07-20	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.	Fruselva America SPA	Elevated levels of thallium (heavy metal)	Class II
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

Other records from PBM Nutritionals, LLC

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

Reported	Product	Firm	Reason	Class
2024-09-04	CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite cans; 4 cans per case; UPC 50428318034 and 41220164578	PBM Nutritionals, LLC	Product contains levels of Vitamin D above the maximum level permitted.	Class II
2023-09-13	Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivity Premium Infant Formula, 942g, packaged in composite cans	PBM Nutritionals, LLC	Inadvertent release of rejected product to market	Class III

All 3 records for PBM Nutritionals, LLC

All 2019 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.