Food recall: Iron Drops (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL amber glass bottle packaged in an individual…
Class I FDA enforcement event 86110. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product contains undeclared milk
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Wellements LLC started this food recall on 24 Jul 2020. The firm address in the FDA record is in Scottsdale, AZ. FDA put the recall in Class I. FDA event 86110 has 2 product records. The first FDA enforcement report date is 19 Aug 2020. The record gives the status Terminated, with the termination date 22 Jan 2021.
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.
Nationwide. AZ, CA, CO, CT, FL, IL, IN, MA, OH, PA, SC, TX, WI.
Recalling firm
Wellements LLC, Scottsdale, AZ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-1147-2020 | Iron Drops (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL amber glass bottle packaged in an individual product carton that includes a 1 mL oral syringe dispenser. | 27,557 bottles | Class I | Terminated | 19 Aug 2020 |
| F-1148-2020 | Iron Drops Sampler (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL, (2 mL fill) amber glass bottle packaged in an individual product carton that includes a 1 mL oral syringe dispenser. | 20,964 bottles | Class I | Terminated | 19 Aug 2020 |
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 I: The highest of the three FDA recall classes.
The event in context
- Food events that started in 2020
- 381
- Share of these events in Class I
- 35%
- Product records in this event
- 2Median of the firm: 2
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Jul 2012 | Wellements Baby Move Prune Concentrate with Prebiotics, 4oz., 12 units per case, SKU# 141161, UPC 729609019878. Event 62615 | Food | Class I | 1 |
Official channels
- FDA enforcement report F-1147-2020The 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 86110. https://recallregister.com/fda/i/86110/. 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:
Nationwide. AZ, CA, CO, CT, FL, IL, IN, MA, OH, PA, SC, TX, WI.
- What quantity of product is in FDA event 86110?
- The event has 2 product records. The first record gives this quantity:
27,557 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2020 have the same class?
- 35% of the 381 food events that started in 2020 are in Class I.