CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder…
PBM Nutritionals, LLC recalled this product and the FDA reported the enforcement action on 4 September 2024 as Class II. The recall was initiated by the firm. Product contains levels of Vitamin D above the maximum level permitted.
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
- 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
- UPC
- 50428318034
- Reason for recall
- Product contains levels of Vitamin D above the maximum level permitted.
- Recalling firm
- PBM Nutritionals, LLC
- Firm location
- Fairfax, Vermont, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1751-2024
- Quantity
- 16,500 units
- Distribution
- TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, MO
- Initiated
- 5 August 2024
- Reported by FDA
- 4 September 2024
- Terminated
- 4 August 2025
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- CVS brand: T11LMYC - USE BY 11NOV2025 HEB brand: T11LMXC - USE BY 11NOV2025; T09LMXC - USE BY 09NOV2025
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 12 months, from 5 August 2024 to termination on 4 August 2025. 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 12 states, and 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 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: Texas, Florida, California, South Carolina, Virginia, Indiana, Tennessee, New Jersey, Michigan, Pennsylvania, Rhode Island, Missouri. 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 and milk and dairy. 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 |
|---|---|---|---|---|
| 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 |
| 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 2024 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.