Threshold Enterprises Ltd Recall: Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).

🇺🇸 United States

1. December 7, 2018 - Recall initiated
2. March 6, 2019 - Reported by source
3. June 7, 2019 - Recall terminated

Official source record

Agency

FDA

Dataset

FDA Food Enforcement (Recalls)

Recall number

F-1097-2019

Event ID

82088

Status

Terminated

Classification

Class II

Company

Threshold Enterprises Ltd

Product description

Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item number PF0002; 180 count, Item number PF0106 and 90 + 90 count, PF 7013 white plastic bottles. Proprietary Blend: Platycodon root, Ophiopagon Rhizome, Long Pepper Fruit, Black Cherry Bark, Cassia Bark, Elecampane Root, Mullein Leaf, Licorice Root and Ginger Rhizome Extract. Manufactured for: Planetary Herbals LLC. P.O. Box 1760, Soquel, CA 95073

Quantity

16, 542 units

Reason

Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).

Recall initiation date

December 7, 2018

Report date

March 6, 2019

Classification date

Not published in this source record

Termination date

June 7, 2019

Distribution pattern

Nationwide distribution

UPC, lot, and code information

15 count lot number and expiry dates: FG-85657 - 1/21 FG-90863 - 11/21 FG-94415 - 4/22 FG-96010 - 7/22 90 count: FG-84056 - 1/21 FG-90862 - 11/21 FG-94413 - 4/22 FG-96008 - 7/22 180 count: FG-84057 - 1/21 FG-87851 - 1/21 FG-90864 - 11/21 FG-94414 - 4/22 FG-96009 - 7/22 90 + 90 Count: FG-90865 - 11/21 FG-96011 - 7/22

Voluntary or mandated

Voluntary: Firm initiated

Initial notification method

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Source last updated

Not tracked separately from the Public Health Trace retrieval date below

Public Health Trace retrieval date

July 18, 2026 ET

Responsible company: Threshold Enterprises Ltd

Other recalls from Threshold Enterprises Ltd

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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