FDA Recall United States Terminated Historical recordClass I
Wellements LLC
- Product
- Iron Drops Sampler (UPC 729609000098) liquid Dietary Supplem…
- Published
- August 19, 2020
- Distribution
- Nationwide
Wellements LLC Recall: Product contains undeclared milk
United States
TerminatedClass I
- Company
- Wellements LLC
- Product
- Iron Drops (UPC 729609000098) liquid Dietary Supplement, 1 o…
- Recall date
- July 24, 2020
- Terminated
- January 22, 2021
- Source
- FDA
Reason for recall
Product contains undeclared milk
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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. | 729609000098 | 27,557 bottles | Lot 18491 BB 1/2021, Lot 10592 BB 10/2020 |
Distribution
- Nationwide. AZ
- CA
- CO
- CT
- FL
- IL
- IN
- MA
- OH
- PA
- SC
- TX
- WI.
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-1147-2020
- Event ID
- 86110
- Status
- Terminated
- Classification
- Class I
- Company
- Wellements LLC
- Product description
- 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.
- Quantity
- 27,557 bottles
- Reason
- Product contains undeclared milk
- Recall initiation date
- July 24, 2020
- Report date
- August 19, 2020
- Classification date
- Not published in this source record
- Termination date
- January 22, 2021
- Distribution pattern
- Nationwide. AZ, CA, CO, CT, FL, IL, IN, MA, OH, PA, SC, TX, WI.
- UPC, lot, and code information
- UPC 729609000098; Lot 18491 BB 1/2021, Lot 10592 BB 10/2020
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Press Release
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Other products recalled under this same event
This recall shares FDA event ID 86110 with 1 other product entry in Public Health Trace.
Responsible company: Wellements LLC
Other recalls from Wellements LLC
FDA Recall United States Terminated Historical recordClass I
Wellements LLC
- Product
- Iron Drops Sampler (UPC 729609000098) liquid Dietary Supplem…
- Published
- August 19, 2020
- Distribution
- Nationwide
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| Arizona | 1 |
| California | 1 |
| Colorado | 1 |
| Connecticut | 1 |
| Florida | 1 |
| Illinois | 1 |
| Indiana | 1 |
| Massachusetts | 1 |
| Ohio | 1 |
| Pennsylvania | 1 |
| South Carolina | 1 |
| Texas | 1 |
| Wisconsin | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class I mean?
A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
