Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic…
PBM Nutritionals, LLC recalled this product and the FDA reported the enforcement action on 13 September 2023 as Class III. The recall was initiated by the firm. Inadvertent release of rejected product to market
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 brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivity Premium Infant Formula, 942g, packaged in composite cans
- Reason for recall
- Inadvertent release of rejected product to market
- Recalling firm
- PBM Nutritionals, LLC
- Firm location
- Georgia, Vermont, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-1493-2023
- Quantity
- N/A
- Distribution
- IL, AL, IA, GA, MS, IN, AR, CO, FL, VA, OH, WI, PA, NH, AZ, KS, TX, TN, NC, LA, MO, KY, DE, WI
- Initiated
- 16 June 2023
- Reported by FDA
- 13 September 2023
- Terminated
- 30 April 2024
- Firm notified by
- Telephone
- Product codes
- D05LVJV USE BY 05MAR2025 D06LT7VA USE BY 06MAR2025 UPC Codes: 36800496644 and 681131045513
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 10 months, from 16 June 2023 to termination on 30 April 2024. 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 23 states, and the FDA published the enforcement report 3 months after the firm began the recall.
- Recalls of infant formula or baby food run a median of 10 months, so this one was about typical 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: Illinois, Alabama, Iowa, Georgia, Mississippi, Indiana, Arkansas, Colorado, Florida, Virginia, Ohio, Wisconsin, Pennsylvania, New Hampshire, Arizona, Kansas, Texas, Tennessee, North Carolina, Louisiana, Missouri, Kentucky, Delaware. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
Filed under infant formula and baby food. A product can sit in more than one.
Other infant formula and baby food recalls
These are the closest records in the corpus: the same kind of food. 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 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 |
| 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 3 records for PBM Nutritionals, LLC
All 2023 recalls · All FDA food recall data
Behind every recall is a clause 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.