Sundial Herbal Products Recall: Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

🇺🇸 United States

1. June 30, 2020 - Recall initiated
2. September 9, 2020 - Reported by source
3. October 26, 2022 - Recall terminated

Official source record

Agency

FDA

Dataset

FDA Food Enforcement (Recalls)

Recall number

F-1453-2020

Event ID

85882

Status

Terminated

Classification

Class II

Company

Sundial Herbal Products

Product description

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO BARK***2 oz.***USES: KIDNEY STONE, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"

Quantity

Unknown

Reason

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Recall initiation date

June 30, 2020

Report date

September 9, 2020

Classification date

Not published in this source record

Termination date

October 26, 2022

Distribution pattern

NY

UPC, lot, and code information

Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.

Voluntary or mandated

FDA Mandated

Initial notification method

Letter

Source last updated

Not tracked separately from the Public Health Trace retrieval date below

Public Health Trace retrieval date

July 18, 2026 ET

Other products recalled under this same event

This recall shares FDA event ID 85882 with 10 other product entries in Public Health Trace.

Responsible company: Sundial Herbal Products

Other recalls from Sundial Herbal Products

A map highlighting the states named in the source's distribution description.

Distributed No data published

Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.

Distribution map

State	Distributed
New York	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: July 18, 2026 ET

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

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.

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