Food recall: CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite…
Class II FDA enforcement event 95097. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product contains levels of Vitamin D above the maximum level permitted.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
PBM Nutritionals, LLC started this food recall on 5 Aug 2024. The firm address in the FDA record is in Fairfax, VT. FDA put the recall in Class II. FDA event 95097 has 1 product record. The first FDA enforcement report date is 4 Sep 2024. The record gives the status Terminated, with the termination date 4 Aug 2025.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, MO
Recalling firm
PBM Nutritionals, LLC, Fairfax, VT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-1751-2024 | 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 | 16,500 units | Class II | Terminated | 4 Sep 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Food events that started in 2024
- 482
- Share of these events in Class II
- 53%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Jun 2023 | Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivi | Food | Class III | 1 |
| 21 Jan 2019 | Parent's Choice Toddler Next Stage Milk Drink Powder Natural Milk Flavor With Other Natural Flavors, Stage 3, 1 Year and | Food | Class II | 1 |
Official channels
- FDA enforcement report F-1751-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 95097. https://recallregister.com/fda/ii/95097/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, MO
- What quantity of product is in FDA event 95097?
- The FDA record gives this quantity:
16,500 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2024 have the same class?
- 53% of the 482 food events that started in 2024 are in Class II.